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Obturator
EUDAMEDClass I (EU MDR)
Ref N/AModel UBE-FD-GDYZ-XXXX、ENB19X、ENB27X、FDY-A-XX
Identity
- Device Name
- Obturator EUDAMED
- Model / Reference
- UBE-FD-GDYZ-XXXX、ENB19X、ENB27X、FDY-A-XX EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455433979 EUDAMED
- Basic UDI-DI
- 69271553BONSS0096K EUDAMED
- Direct Marketing DI
- 06942455433979 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER 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
Obturator 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 | 69271553BONSS0096K | 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 2da2d899-b6f8-4c2d-91aa-b22338869ff1 61 fields · synced Jun 18, 2026