Identity
- Device Name
- Disposable Burs EUDAMED
- Model / Reference
- SE102-8CDES60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936260866930 EUDAMED
- Basic UDI-DI
- B-06936260866930 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
Category: Spinal shaver system blade
Disposable Burs by Hicren (Zhejiang) Medtech Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal shaver system blade.
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Diamond Abrasor, Ball Tip, Coarse — Joimax GmbH · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
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-06936260866930 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hicren (Zhejiang) Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000025999
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 8441e696-b4c0-4b40-b74f-046f5b7d34e2 61 fields · synced Jul 24, 2026