Identity
- Trade Name
- A-CP-Kit-3 (8ml) FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- A-CP-Kit-3 (8ml) containing 3 x A-CP 8 ml tubes. FDA UDI
- Model / Reference
- A-CP-3-8ml FDA UDI
- Description
- A-CP-Kit-3 (8ml) containing 3 x A-CP 8 ml tubes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138981784 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Haematological concentrate system preparation kit, platelet concentration
A-CP-Kit-3 (8ml) by Regen Lab Sa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Regen Lab Sa
Sources (2)
- FDA UDI ebcba607-b358-4ebb-8a2b-7082e4f3fa69 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026