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Dermaclose
EUDAMEDClass IIa (EU MDR)
Ref GEM204020Ref GEM204010
by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.)
Identity
- Trade Name
- DERMACLOSE EUDAMED
- Device Name
- DERMACLOSE EUDAMED
- Model / Reference
- GEM204020 EUDAMEDGEM204010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00197886006582 EUDAMED00197886006575 EUDAMED
- Basic UDI-DI
- 4781800000000000000012882 EUDAMED
- EMDN Code
- H02010201 SKIN CLIPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dermaclose by Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.) — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4781800000000000000012882 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000034162
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (2)
- EUDAMED abea0705-7c02-48bc-8e80-5f5e0fe80c8e 61 fields · synced Oct 6, 2026
- EUDAMED 01307b59-4d73-47df-b569-fbe31aa1e312 61 fields · synced May 18, 2026