# Accessory set

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/accessory-set-bca-set3>
- Manufacturer: [Regen Lab SA](https://devicerts.com/manufacturers/regen-lab-sa) (Switzerland)
- Device class: Class IIa (EU MDR)
- EMDN: A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS
- GMDN: Venous butterfly needle/set (58490)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 764013898BCASETCB · UDI-DI 07640138980329 · registered 2025-10-07 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07640138980329 · listed 2020-10-13 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Generic name: Venous butterfly needle/set [FDA GUDID (AccessGUDID)]
- Model / reference: BCA-SET3 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07640138980329 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 764013898BCASETCB [EUDAMED]
- EMDN code: A01010501 [EUDAMED]
- GMDN term: Venous butterfly needle/set (58490) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]
- System or procedure pack: Procedure pack [EUDAMED]
- EU registration type: System or procedure pack [EUDAMED]
- Medical purpose: Accessory set for blood collection to be used with RegenKit® [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: No [EUDAMED]; Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Accessory set, Regen Lab SA. deviCERTS medical device catalogue. https://devicerts.com/devices/accessory-set-bca-set3 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/accessory-set-bca-set3.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/accessory-set-bca-set3
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.