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Newborn Blood Spot Collection Card
EUDAMEDClass A (EU MDR)
Ref 250701Model NBA, NBB, NBC
Identity
- Trade Name
- Newborn Blood Spot Collection Card EUDAMED
- Device Name
- Newborn Blood Spot Collection Card EUDAMED
- Model / Reference
- NBA, NBB, NBC EUDAMED250701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931304861 EUDAMED06955931304847 EUDAMED
- Basic UDI-DI
- 695593130025070001LA EUDAMED
- Direct Marketing DI
- 06955931304861 EUDAMED06955931304847 EUDAMED
- EMDN Code
- W0501010299 CAPILLARY BLOOD COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Newborn Blood Spot Collection Card by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 695593130025070001LA | Class A | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED df1d154b-5dd2-4ee6-919a-260b6ef6bce2 61 fields · synced Jul 27, 2026
- EUDAMED bd1e52c9-4063-4f52-9d6c-141e4c9e606e 61 fields · synced May 19, 2026