Identity
- Trade Name
- CER-PRP-DOUBLE EUDAMEDCervos Platelet Separator Double Pack FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Cervos Platelet Separator (CPS) EUDAMEDCER-PRP-DOUBLE TRIPLE PACK F/G, STERILE PN 76126-01M FDA UDI
- Model / Reference
- 76126-01M EUDAMEDCER-PRP-DOUBLE FDA UDI
- Description
- CER-PRP-DOUBLE TRIPLE PACK F/G, STERILE PN 76126-01M FDA UDI
Identifiers
- Catalog Number
- CER-PRP-DOUBLE FDA UDI
- Primary DI / UDI-DI
- 10850023741650 EUDAMEDFDA UDI
- Basic UDI-DI
- 08500237418303701Y9 EUDAMED
- Direct Marketing DI
- 10850023741650 EUDAMED
- FDA Product Code
- ORG FDA UDI
- EMDN Code
- B010202 PLATELETS CONCENTRATE TRANSFER BAGS AND KITS EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 80 Milliliter FDA UDI
Cer-Prp-Double by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08500237418303701Y9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
- EUDAMED SRN
- US-MF-000008871
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c3509d46-fad1-4215-ab7d-4086d7947b9d 61 fields · synced Jul 23, 2026
- FDA UDI e12184ef-26c9-4253-9468-2cce6b5d5837 38 fields · synced May 29, 2026