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PriMatrix® 607-005-125

by Tei Biosciences Inc.

Ref 607-005-125

PriMatrix 607-005-125 is an animal-derived wound matrix dressing (EU MDD Class III; FDA unclassified; FDA product code KGN, Dressing, Wound, Collagen) made by Tei Biosciences Inc., registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI B-10381780113409), cleared under FDA 510(k) K153690 on 22 Feb 2016 and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 10381780113409), active as of 25 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153690

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780113409 Basic UDI-DI 10381780113409UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153690 Date22 Feb 2016DecidedStatusActive
United StatesGUDID listing GUDID Number10381780113409 UDI-DI Date23 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780113409 registered 18 Aug 2026 Active
  • FDA 510(k) K153690 decided 22 Feb 2016 Active
  • FDA GUDID UDI-DI 10381780113409 listed 23 Oct 2015 Listed

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2078-2023 FDA Class II initiated 23 May 2023
    • Ongoing Z-2077-2023 FDA Class II initiated 23 May 2023
    • Ongoing Z-2079-2023 FDA Class II initiated 23 May 2023

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    • Terminated Z-0383-2018 FDA Class II initiated 15 Jun 2017

    During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.

Timeline

7 dated events

  1. Listed FDA GUDID 10381780113409
  2. Cleared FDA 510(k) K153690
  3. Recall initiated FDA recalls Z-0383-2018
  4. Recall initiated FDA recalls Z-2078-2023
  5. Recall initiated FDA recalls Z-2077-2023
  6. Recall initiated FDA recalls Z-2079-2023
  7. Registered EUDAMED B-10381780113409

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
PriMatrix®
Generic name
Animal-derived wound matrix dressing
Device name
Dermal Repair Scaffold
Model / Ref / Catalog
607-005-125
Primary DI / UDI-DI
10381780113409
Basic UDI-DI
B-10381780113409
510(k) Number
FDA product code
KGN
EMDN code
M0499 Special dressings - other
GMDN term
Animal-derived wound matrix dressing
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Animal-derived wound matrix dressing

Cleared under the same submission (K153690)

and 8 more cleared under K153690

Similar devices in this category

Other devices filed under SPECIAL DRESSINGS - OTHER.

Other devices from Tei Biosciences Inc.

See all devices from Tei Biosciences Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)