Identity
- Trade Name
- Birdy Suture Passer, Upbiter EUDAMED
- Device Name
- Punch, Forceps, Retriever, Suture Passer EUDAMED
- Model / Reference
- ZXCr EUDAMEDZXCr7384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973486980316 EUDAMED
- Basic UDI-DI
- 697348698zx001E7 EUDAMED
- EMDN Code
- L031309 SUTURE NEEDLE PASSERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Birdy Suture Passer, Upbiter by Qingdao Zhixing Medical Instrument 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 | 697348698zx001E7 | Class I | Active |
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Manufacturer
- Manufacturer
- Qingdao Zhixing Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000024667
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED fb51fd6a-b30f-4f45-b227-e73f565d6a09 61 fields · synced Jun 18, 2026