Identity
- Trade Name
- Single-use Sterile Bur EUDAMED
- Device Name
- Single-use Sterile Bur EUDAMED
- Model / Reference
- BZTM11540QH.DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955709845565 EUDAMED
- Basic UDI-DI
- 695570989971QS EUDAMED
- EMDN Code
- Q030302 ENT SURGERY BURS AND HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single-use Sterile Bur by Chongqing Xishan Science & Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 695570989971QS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chongqing Xishan Science & Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009650
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 9b819504-b783-4d8e-ac80-28ff6245f4c6 61 fields · synced Jul 26, 2026