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Syringes

by OriGen Biomedical Inc. 4 variants

Ref R3F-T15, 15-R6F-TA, 15-RF12-T

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number20816203020196 UDI-DI Date18 Jun 2025ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED NumberB-20816203020196 Basic UDI-DI Date20 Mar 2024RegisteredStatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Syringes EUDAMED
Accessories GUDID
Generic Name
Blood transfer set
Device Name
R3F-T15
15-R6F-Ta
15-RF12-T
Model / Ref / Catalog
R3F-T15, 15-R6F-TA, 15-RF12-T
Primary DI / UDI-DI
20816203020196 EUDAMED
20816203023449 EUDAMED
20816203023043 EUDAMED
10816203023879 GUDID
10816203023862 GUDID
10816203023947 GUDID
Basic UDI-DI
B-20816203020196, B-20816203023449, B-20816203023043
FDA Product Code
KJG
EMDN Code
B0180 Blood bags and kits - accessories
GMDN Term
Blood transfer set
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20816203020196
20816203023449
20816203023043
GUDID
10816203023879
10816203023862
10816203023947
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000018098
Authorised representative
Advena Limited MT-AR-000000234

Other devices from OriGen Biomedical Inc.

See all devices from OriGen Biomedical Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No