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Chisel
EUDAMEDClass I (EU MDR)
Ref N/AModel UBE-B-xxxx-xxxx、UBE-D-GZCZ-1205、UBE-FD-GZQZ-1205、UBE-FD-GZQY-1205、UBE-FD-GZSQ-xxxx、UBE-FD-GZCZ-xxxx、UBE-FD-GZCL-xxxx、UBE-FD-GZHZ-xxxx、UBE-FD-GZHW-xxxx、UBE-FD-GZBW-xxxx、
Identity
- Device Name
- Chisel EUDAMED
- Model / Reference
- UBE-B-xxxx-xxxx、UBE-D-GZCZ-1205、UBE-FD-GZQZ-1205、UBE-FD-GZQY-1205、UBE-FD-GZSQ-xxxx、UBE-FD-GZCZ-xxxx、UBE-FD-GZCL-xxxx、UBE-FD-GZHZ-xxxx、UBE-FD-GZHW-xxxx、UBE-FD-GZBW-xxxx、 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455434198 EUDAMED
- Basic UDI-DI
- 69271553BONSS16878 EUDAMED
- Direct Marketing DI
- 06942455434198 EUDAMED
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Chisel by Jiangsu Bonss Medical Technology Co., Ltd. — Class I — 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 | 69271553BONSS16878 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bonss Medical Technology Co Ltd
- EUDAMED SRN
- CN-MF-000023743
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 20fb1a45-3774-4ca3-ad4b-34f22f2c9680 61 fields · synced Jun 19, 2026