Regen Spray Applicator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by Regen Lab SA
Identity
- Trade Name
- Regen Spray Applicator EUDAMEDFDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Regen Spray Applicator EUDAMED
- Model / Reference
- R-A/NAC1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138980220 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640138980220 EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Regen Spray Applicator by Regen Lab Sa — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122122 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640138980220 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-MF-000032231
- Authorised Representative
- RegenLab France FR-AR-000011953
Sources (3)
- EUDAMED 9c1fd899-fa80-4dd7-875d-5aecd93b74f3 61 fields · synced Jul 11, 2026
- FDA UDI dc93af0f-934a-4846-ae24-45798da32a60 33 fields · synced May 30, 2026
- FDA 510(k) K122122 1 fields · synced May 18, 2026