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Shannon Ishan Burr 2x12
EUDAMEDClass IIa (EU MDR)
Ref 38.37.03Model BURR
by Ortho Cape
Identity
- Trade Name
- Shannon Ishan Burr 2x12 EUDAMED
- Device Name
- Shannon Ishan Burr 2x12 EUDAMED
- Model / Reference
- BURR EUDAMED38.37.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760347450025 EUDAMED
- Basic UDI-DI
- B-03760347450025 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
Shannon Ishan Burr 2x12 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-03760347450025 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ortho Cape
- EUDAMED SRN
- FR-MF-000028862
Sources (1)
- EUDAMED 95d197e2-5b1d-4cb5-90e7-bdc38554e951 61 fields · synced Jun 18, 2026