Identity
- Device Name
- Disposable Burs EUDAMED
- Model / Reference
- SE102-8DS40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260815303 EUDAMED
- Basic UDI-DI
- B-06936260815303 EUDAMED
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Disposable Burs by Hicren (Zhejiang) Medtech Co., Ltd. — 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-06936260815303 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hicren (Zhejiang) Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 714f829c-8aa4-4458-8d38-5f03a440c2de 61 fields · synced Jul 29, 2026