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Germany

FREY-TOX

Osteroda 38, 04916, Herzberg, Germany

DAKKS|D-PL-20600-01-00ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
6
Standards
11
Locations
1

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Register record

DAKKSRefreshed
D-PL-20600-01-00Active

Accredited standards

11

Our reading of the DAKKS scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

ISO 10993 series

ISO 10993-1Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
As written on the certificate · Line 2 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2

As written on the certificate · Line 3 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11

As written on the certificate · Line 4 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>

As written on the certificate · Line 5 (DAKKS D-PL-20600-01-00)

ISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666

ISO 10993-2Biological evaluation of medical devices - Part 2: Animal welfare requirements
As written on the certificate · Line 2 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2

As written on the certificate · Line 3 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11

As written on the certificate · Line 4 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>

As written on the certificate · Line 5 (DAKKS D-PL-20600-01-00)

ISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 2 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2

ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
As written on the certificate · Line 2 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2

ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
As written on the certificate · Line 3 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11

ISO 10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
As written on the certificate · Line 3 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11

As written on the certificate · Line 4 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>

As written on the certificate · Line 6 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32

ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
As written on the certificate · Line 2 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2

As written on the certificate · Line 3 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11

As written on the certificate · Line 4 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>

As written on the certificate · Line 5 (DAKKS D-PL-20600-01-00)

ISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666

As written on the certificate · Line 6 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32

ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation
As written on the certificate · Line 5 (DAKKS D-PL-20600-01-00)

ISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666

As written on the certificate · Line 6 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32

USP

USP 43Name not checked yet
As written on the certificate · Line 6 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32

USP 151Name not checked yet
As written on the certificate · Line 4 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>

USP 881Name not checked yet
As written on the certificate · Line 5 (DAKKS D-PL-20600-01-00)

ISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666

As written on the certificate · Line 6 (DAKKS D-PL-20600-01-00)

DIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32

Scope as published by DAKKS

6 lines
DAKKS

ISO/IEC 17025

Active

D-PL-20600-01-00

View scope

Accredited scope, certificate D-PL-20600-01-00

LineDisciplineMethodMatrixRange
1biological-Pharmaceuticals-
2biologicalDIN EN ISO 10993-5; DIN EN ISO 10993-1; DIN EN ISO 10993-12; DIN EN ISO 10993-6; DIN EN ISO 10993-2--
3biologicalDIN EN ISO 10993-10; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; DIN EN ISO 10993-11--
4biologicalDIN EN ISO 10993-11; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; Ph. Eur., 2.6.8; USP <151>--
5biological; materialsISO 10993-23; DIN EN ISO 10993-1; DIN EN ISO 10993-2; DIN EN ISO 10993-12; USP<881>; Ph. Eur./ Einzelmonographien 0324, 0667, 0666--
6biologicalDIN EN ISO 10993-11; DIN EN ISO 10993-12; DIN EN ISO 10993-23; Ph. Eur. 11, 2.6.8; Ph. Eur. 10; USP 43 <151>; USP <881>; SV/VS/09; SV/VS/10; SV/VS/22; SV/VS/25; SV/VS/26; SV/VS/30; SV/VS/35; SV/VS/36; SV/VS/37; SV/VS/38; SV/VS/39; SV/PYROGENE/32Pharmaceuticals-

Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

Osteroda 38, Herzberg, 04916, DE

51.68007, 13.30188

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Accreditation data refreshed from the DAKKS register on .

This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the DAKKS entry linked above.