Identity
- Trade Name
- unidix EUDAMED
- Device Name
- Safety Blood Collection Needle;Safety Blood Collection Needle with Pre-attached Holder;Safety Winged Infusion Set EUDAMED
- Model / Reference
- Type H、Type A、Type S EUDAMEDRBC-2519A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111920750 EUDAMED
- Basic UDI-DI
- 697122740RBCPE EUDAMED
- Unit of Use DI
- 86978111920756 EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
unidix 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 | 697122740RBCPE | 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 02ad6c92-12e5-4a4a-8eba-7e6746faa657 61 fields · synced Jun 18, 2026