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Dilator
EUDAMEDClass I (EU MDR)
Ref N/AModel UBE-A-KZGQ-XXXX、UBE-A-KZGN-XXXX、UBE-A-KZGS-XXXX、UBE-A-KZGB-XXXX、UBE-A-KZGJ-XXXX、UBE-FD-KZGN-XXXX、UBE-FD-KZGP-XXXX、UBE-FD-KZGS-XXXX、UBE-FD-KZGB-XXXX、UBE-FD-KZGK-XXXX、UBE-FD-KZGJ-XXXX
Identity
- Device Name
- Dilator EUDAMED
- Model / Reference
- UBE-A-KZGQ-XXXX、UBE-A-KZGN-XXXX、UBE-A-KZGS-XXXX、UBE-A-KZGB-XXXX、UBE-A-KZGJ-XXXX、UBE-FD-KZGN-XXXX、UBE-FD-KZGP-XXXX、UBE-FD-KZGS-XXXX、UBE-FD-KZGB-XXXX、UBE-FD-KZGK-XXXX、UBE-FD-KZGJ-XXXX EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455432958 EUDAMED
- Basic UDI-DI
- 69271553BONSS1626U EUDAMED
- EMDN Code
- L0925 ORTHOPAEDIC SURGERY DILATORS, 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
Dilator 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 | 69271553BONSS1626U | 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 60af9e08-2e16-4fdd-a490-79ded1c64e80 61 fields · synced Jun 18, 2026