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REGEN1

by Pharmatech SRL

Ref REGEN1

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805612503REGEN8D Basic UDI-DI 08056125030004UDI-DIDate30 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
REGEN1
Primary DI / UDI-DI
08056125030004
Basic UDI-DI
805612503REGEN8D
EMDN Code
A0680 Drainage and fluid collection devices - accessories
Device Class
Class IIa
Medical Purpose
Soft Harvest System consists of single-use instrumentation/devices intended for closed-system harvesting and processing of lipoaspirate in medical procedures involving the harvesting, concentrating, and transferring of autologous adipose tissue. The devices are intended for use in the following surgical specialties when the transfer of adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, dermatological surgery and plastic and reconstructive surgery when aesthetic body contouring is intended.

Manufacturer details

EUDAMED SRN
IT-PR-000052268

Other devices from Pharmatech SRL

Properties

  • Sterile