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MatriDerm
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref 83462-200Model MatriDerm510(k) K261224Ref 83410-200Ref 83442-200Ref 83405-200Ref 83430-200Ref 83420-200Ref 83433-200Ref 83432-200Ref 83431-200Ref 83460-200Ref 83473-200Ref 83404-200Ref 83463-200Ref 83440-200Ref 83412-200Ref 83472-200
Identity
- Trade Name
- MatriDerm EUDAMED
- Device Name
- MatriDerm Flex Dermal Matrix EUDAMEDMatriDerm Fenestrated Dermal Matrix EUDAMEDMatriDerm Dermal Matrix EUDAMED
- Model / Reference
- MatriDerm EUDAMED83462-200 EUDAMED83410-200 EUDAMED83442-200 EUDAMED83405-200 EUDAMED83430-200 EUDAMED83420-200 EUDAMED83433-200 EUDAMED83432-200 EUDAMED83431-200 EUDAMED83460-200 EUDAMED83473-200 EUDAMED83404-200 EUDAMED83463-200 EUDAMED83440-200 EUDAMED83412-200 EUDAMED83472-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250569301469 EUDAMED04250569301285 EUDAMED04250569301421 EUDAMED04250569300899 EUDAMED04250569301360 EUDAMED04250569301322 EUDAMED04250569301391 EUDAMED04250569301384 EUDAMED04250569301377 EUDAMED04250569301445 EUDAMED04250569301513 EUDAMED04250569300011 EUDAMED04250569301476 EUDAMED04250569301407 EUDAMED04250569301308 EUDAMED04250569301506 EUDAMED
- Basic UDI-DI
- B-04250569301469 EUDAMEDB-04250569301285 EUDAMEDB-04250569301421 EUDAMEDB-04250569300899 EUDAMEDB-04250569301360 EUDAMEDB-04250569301322 EUDAMEDB-04250569301391 EUDAMEDB-04250569301384 EUDAMEDB-04250569301377 EUDAMEDB-04250569301445 EUDAMEDB-04250569301513 EUDAMEDB-04250569300011 EUDAMEDB-04250569301476 EUDAMEDB-04250569301407 EUDAMEDB-04250569301308 EUDAMEDB-04250569301506 EUDAMED
- EMDN Code
- P900404 AUTOLOGOUS GRAFT SUPPORTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MatriDerm by MedSkin Solutions Dr. Suwelack AG — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K261224 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K201577 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04250569301469 | Class III | Active |
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Manufacturer
- Manufacturer
- Medskin Solutions Dr. Suwelack AG
- EUDAMED SRN
- DE-MF-000007747
Sources (17)
- EUDAMED ecc6bc96-d932-4510-8350-10793f86d353 85 fields · synced Jul 29, 2026
- EUDAMED 565c58af-a3c5-45a0-9185-f71981b413a8 61 fields · synced May 16, 2026
- EUDAMED b1c41d5c-6352-487e-84a8-14a148b9320a 61 fields · synced May 16, 2026
- EUDAMED 013b0604-d3cf-423b-963c-8324f41bd8f6 61 fields · synced May 17, 2026
- EUDAMED 6321aa2f-029e-4ff0-ba28-336a1ae49d7f 61 fields · synced May 17, 2026
- EUDAMED 27a30188-a09e-476f-8d46-82339f20f79f 61 fields · synced May 17, 2026
- EUDAMED 3e397e21-abc0-4efd-9544-5d0b33877e59 61 fields · synced May 17, 2026
- EUDAMED 4aae6cbc-3266-42b0-ab07-0234946f0bf0 61 fields · synced May 17, 2026
- EUDAMED de4cebce-19f4-4ca5-874c-289adc51d008 61 fields · synced May 18, 2026
- EUDAMED 76ba0fe5-e59c-4376-a430-81f4a0e0d875 61 fields · synced May 18, 2026
- EUDAMED 54dc14c0-03a3-4ac4-8fe4-d80be2049b33 61 fields · synced May 18, 2026
- EUDAMED a7a6ff32-3471-4f4a-ba87-8e30e334913c 61 fields · synced May 18, 2026
- EUDAMED a85f67c1-0f8d-468d-8d1a-6cbc88f95591 61 fields · synced Jul 9, 2026
- EUDAMED 3c59bf90-453c-425d-a60d-c7738d51cc69 61 fields · synced Jul 18, 2026
- EUDAMED f0a16d65-6e71-4608-8aae-c0fc379c340f 61 fields · synced Jul 25, 2026
- EUDAMED 666f9402-55d2-4b3b-ac07-6a5cc9e3066b 61 fields · synced Jul 26, 2026
- FDA 510(k) K261224 1 fields · synced May 29, 2026