Identity
- Trade Name
- Accessory set EUDAMEDFDA UDI
- Generic Name
- Venous butterfly needle/set FDA UDI
- Device Name
- Accessory set EUDAMED
- Model / Reference
- BCA-SET3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640138980329 EUDAMEDFDA UDI
- Basic UDI-DI
- 764013898BCASETCB EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Venous butterfly needle/set FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Accessory set for blood collection to be used with RegenKit® EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Accessory set by Regen Lab Sa — 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 | 764013898BCASETCB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-PR-000049402
Sources (2)
- EUDAMED e47dc728-e132-4c83-af66-6bc0ddddfa10 61 fields · synced Jul 10, 2026
- FDA UDI 324bcf58-7c0c-413a-be89-e01f681d69f4 33 fields · synced May 30, 2026