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Wedge Burr 3.1x 13
EUDAMEDClass IIa (EU MDR)
Ref 38.37.04Model BURR
by Ortho Cape
Identity
- Trade Name
- Wedge Burr 3.1x 13 EUDAMED
- Device Name
- Wedge Burr 3.1x 13 EUDAMED
- Model / Reference
- BURR EUDAMED38.37.04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760347450032 EUDAMED
- Basic UDI-DI
- B-03760347450032 EUDAMED
- EMDN Code
- Q030302 ENT SURGERY BURS AND HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wedge Burr 3.1x 13 by Ortho Cape — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760347450032 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ortho Cape
- EUDAMED SRN
- FR-MF-000028862
Sources (1)
- EUDAMED f9e64731-affd-467a-acc6-bee3bab847aa 61 fields · synced Aug 1, 2026