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Blood Collection Set (with Safety)
EUDAMEDClass IIa (EU MDR)
Ref 88312Model Blood Collection Set (with Safety)
Identity
- Trade Name
- Blood Collection Set (with Safety) EUDAMED
- Device Name
- Blood Collection Set with/ without Safety features EUDAMED
- Model / Reference
- Blood Collection Set (with Safety) EUDAMED88312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095883129 EUDAMED
- Basic UDI-DI
- 890209588291JA EUDAMED
- EMDN Code
- A01018099 NEEDLES FOR INFUSION AND COLLECTION - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Blood Collection Set (with Safety) by Poly Medicure Limited — 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 | 890209588291JA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043009
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6a492bb1-baf3-431d-ba67-b00dc0de5629 61 fields · synced Aug 1, 2026