Identity
- Device Name
- Surgical Powered Tools System EUDAMED
- Model / Reference
- SE101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260855750 EUDAMED
- Basic UDI-DI
- B-06936260855750 EUDAMED
- EMDN Code
- Z12130501 MOTORISED ORTHOPAEDIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Surgical Powered Tools System 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-06936260855750 | 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 ccea9562-ff5f-41e4-b147-a9fde77aa457 61 fields · synced Jun 19, 2026