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Manifold Sets

by OriGen Biomedical Inc. 2 variants

Ref 40-PF-2M, 4S-4M60

Active European Union. Also listed in GUDID (US), partly 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
European UnionCE/MDD EUDAMED NumberB-20816203023432 Basic UDI-DI Date19 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number20816203023432 UDI-DI Date14 Aug 2018ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

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  • Withdrawn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
Manifold Sets EUDAMED
Accessories GUDID
Generic Name
Blood transfer set
Device Name
40-Pf-2M
4S-4M60
Model / Ref / Catalog
40-PF-2M, 4S-4M60
Primary DI / UDI-DI
20816203023432 EUDAMED
20816203020035 EUDAMED
10816203023435 GUDID
10816203024180 GUDID
Basic UDI-DI
B-20816203023432, B-20816203020035
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
In Commercial Distribution (UDI-DI 10816203023435)
Not in Commercial Distribution (UDI-DI 10816203024180)

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20816203023432
20816203020035
GUDID
10816203023435
10816203024180
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

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

From the manufacturer

Manufacturer's product page: Manifold Sets

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