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Winged Blood Collection /Infusion Sets:
EUDAMEDClass IIa (EU MDR)
Ref WBC-2130AModel Type H, Type A, Type S
Identity
- Device Name
- Winged Blood Collection /Infusion Sets: EUDAMED
- Model / Reference
- Type H, Type A, Type S EUDAMEDWBC-2130A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111921825 EUDAMED
- Basic UDI-DI
- 697122740WBCQ7 EUDAMED
- Unit of Use DI
- 86978111921821 EUDAMED
- EMDN Code
- A01010502 NEEDLES FOR COLLECTION UNDER VACUUM, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Winged Blood Collection /Infusion Sets: by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — 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 | 697122740WBCQ7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 665f448c-4d3c-4079-8350-02ef17fc4a28 61 fields · synced Oct 6, 2026