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Sterile PRP Blood Separation Kit
EUDAMEDClass IIa (EU MDR)
Ref 880941604001G4Model YCELLBIO-KIT
Identity
- Trade Name
- Sterile PRP Blood Separation Kit EUDAMED
- Device Name
- Sterile PRP Blood Separation Kit EUDAMED
- Model / Reference
- YCELLBIO-KIT EUDAMED880941604001G4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809416040011 EUDAMED
- Basic UDI-DI
- 880941604001G4 EUDAMED
- Direct Marketing DI
- 08809416040011 EUDAMED
- EMDN Code
- B0402 INTRA- AND POSTOPERATIVE BLOOD COLLECTION AND REINFUSION ONLY DEVICES AND KITS 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
Sterile PRP Blood Separation Kit by Ycellbio Medical 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 | 880941604001G4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ycellbio Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008619
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 856d0bbf-f531-44cc-9857-691779595b7a 61 fields · synced Jun 19, 2026