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Embra® Surgical cap Tricolor, blue/white/blue
EUDAMEDClass I (EU MDR)
Ref 277003
Identity
- Trade Name
- Embra® Surgical cap Tricolor, blue/white/blue EUDAMED
- Device Name
- Surgical Caps, non-sterile EUDAMED
- Model / Reference
- 277003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129370102 EUDAMED06438129001143 EUDAMED
- Basic UDI-DI
- 6438129B0042HA EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Embra® Surgical cap Tricolor, blue/white/blue by OneMed Group Oy — 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 | 6438129B0042HA | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED 833e5e58-fedb-4c47-b4bf-56139bd8625a 61 fields · synced Jul 10, 2026
- EUDAMED 2f4a1467-1af3-4963-9db8-925e9f04f29e 61 fields · synced May 19, 2026