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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
- 06942455434068 EUDAMED06942455433993 EUDAMED06942455434044 EUDAMED06942455434006 EUDAMED06942455434105 EUDAMED06942455434020 EUDAMED06942455434037 EUDAMED06942455434112 EUDAMED06942455433962 EUDAMED06942455434075 EUDAMED06942455433955 EUDAMED06942455434099 EUDAMED06942455434082 EUDAMED
- Basic UDI-DI
- 69271553BONSS0096K EUDAMED
- Direct Marketing DI
- 06942455434068 EUDAMED06942455433993 EUDAMED06942455434044 EUDAMED06942455434006 EUDAMED06942455434105 EUDAMED06942455434020 EUDAMED06942455434037 EUDAMED06942455434112 EUDAMED06942455433962 EUDAMED06942455434075 EUDAMED06942455433955 EUDAMED06942455434099 EUDAMED06942455434082 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 (13)
- EUDAMED d92ade24-5de5-45f2-be36-c8d459213d48 61 fields · synced Aug 3, 2026
- EUDAMED eba0b7a7-4b92-4997-8c28-d4efb938e8ce 61 fields · synced May 17, 2026
- EUDAMED 48d3e16f-f6d6-4409-aabb-60e02dc0757c 61 fields · synced May 17, 2026
- EUDAMED b8bf4163-2d37-4d27-91f1-16bf037aac34 61 fields · synced May 17, 2026
- EUDAMED c156b0dd-1155-421d-a6bc-2bd6874a6e27 61 fields · synced May 17, 2026
- EUDAMED df6cb264-f1fb-426b-bc5d-7cc1864ff80c 61 fields · synced May 17, 2026
- EUDAMED 81e846ba-1bec-49ee-9adf-57021123defd 61 fields · synced May 19, 2026
- EUDAMED 7b4b050b-a96a-4957-8c64-7463c2df4d0b 61 fields · synced May 19, 2026
- EUDAMED 4678cf15-5477-4f5e-8e44-34ee59f13fe3 61 fields · synced May 19, 2026
- EUDAMED 519987ef-31da-4f00-8ace-a5c9a170fab9 61 fields · synced May 19, 2026
- EUDAMED e685da55-79f6-4f52-9dce-17566417f2b3 61 fields · synced May 19, 2026
- EUDAMED 13d87c83-c7bb-4b92-9d05-ed266ba2e33d 61 fields · synced May 19, 2026
- EUDAMED 0ac27dc4-d904-450f-8c15-fe49e5b49540 61 fields · synced May 19, 2026