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Scar Fx Silicone Sheeting 1.25" x 1.25" (Qty 6)
EUDAMEDClass I (EU MDR)
Ref 16125Model 11111
by Scar Heal
Identity
- Trade Name
- Scar Fx Silicone Sheeting 1.25" x 1.25" (Qty 6) EUDAMED
- Device Name
- Scar Fx Silicone Sheeting EUDAMED
- Model / Reference
- 11111 EUDAMED16125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00642790161259 EUDAMED
- Basic UDI-DI
- 64279011111PW EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Scar Fx Silicone Sheeting 1.25" x 1.25" (Qty 6) by Scar Heal — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 64279011111PW | Class I | Active |
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Manufacturer
Sources (1)
- EUDAMED e0be07d7-ce43-4201-bde6-0b41fc2f7d98 61 fields · synced Oct 6, 2026