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Accessory Set
EUDAMEDClass IIa (EU MDR)
Ref EK-SET3Ref BCA-SET3-20-EU
by Regen Lab SA
Identity
- Trade Name
- Accessory Set EUDAMED
- Device Name
- Accessory Set EUDAMED
- Model / Reference
- EK-SET3 EUDAMEDBCA-SET3-20-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138982019 EUDAMED07640138980114 EUDAMED
- Basic UDI-DI
- 0764013898EKSET3C EUDAMED764013898BCASETCB EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Accessory set for blood collection to be used with ENKO Kits EUDAMEDAccessory set for blood collection to be used with RegenKit® EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Accessory Set by Regen Lab Sa — 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 | 0764013898EKSET3C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-PR-000049402
Sources (2)
- EUDAMED a97b8b9e-3692-417e-bf08-056ff59984bb 61 fields · synced Jul 25, 2026
- EUDAMED 6642e66c-4b15-4330-9d16-98fba93e3eb1 61 fields · synced Jul 25, 2026