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PRP Kit with anticoagulant
EUDAMEDClass IIa (EU MDR)
Ref EU-PRP(G)-20BModel HBH-(PRP Kit-08A,PRP Kit-08B, PRP Kit-08C, PRP Kit-08D, PRP Kit-10A, PRP Kit-10B,PRP Kit-10C,PRP Kit-10D,PRP Kit-12A,PRP Kit-12B,PRP Kit-12C,PRP Kit-12D,PRP Kit-20A,PRP Kit-20B,PRP Kit-20C,PRP Kit-20D,PRP Kit-30A,PRP Kit-30B,PRP Kit-30C,PRP Kit-30D)
Identity
- Device Name
- PRP Kit with anticoagulant EUDAMED
- Model / Reference
- HBH-(PRP Kit-08A,PRP Kit-08B, PRP Kit-08C, PRP Kit-08D, PRP Kit-10A, PRP Kit-10B,PRP Kit-10C,PRP Kit-10D,PRP Kit-12A,PRP Kit-12B,PRP Kit-12C,PRP Kit-12D,PRP Kit-20A,PRP Kit-20B,PRP Kit-20C,PRP Kit-20D,PRP Kit-30A,PRP Kit-30B,PRP Kit-30C,PRP Kit-30D) EUDAMEDEU-PRP(G)-20B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924464103630 EUDAMED
- Basic UDI-DI
- 69244641005TG EUDAMED
- Direct Marketing DI
- 06924464103630 EUDAMED
- EMDN Code
- B030101 APHERESIS PLASMA COLLECTION DEVICES 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
Yes
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
Yes
EUDAMED
PRP Kit with anticoagulant by Beijing Hanbaihan Medical Devices 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 | 69244641005TG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Hanbaihan Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000028967
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 203264d7-dc4f-4141-bb98-ec0a0c8f77b7 61 fields · synced Jul 8, 2026