Skip to content

Biophen Normal Control Plasma 223201

by Hyphen Biomed

Ref 223201Model Control Normal Plasma

Biophen Normal Control Plasma 223201 is a device classified as Class C in the EU and Class II in the US made by Hyphen Biomed, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 366353700034B6), cleared under FDA 510(k) K083729 on 8 May 2009 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 03663537008306), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083729

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number366353700034B6 Basic UDI-DI 03663537008306UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03663537008306 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083729 Date8 May 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 366353700034B6 registered 24 Jul 2026 Active
  • FDA 510(k) K083729 decided 8 May 2009 Active
  • FDA GUDID UDI-DI 03663537008306 listed 25 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083729
  2. Listed FDA GUDID 03663537008306
  3. Registered EUDAMED 366353700034B6

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
BIOPHEN™ Normal Control Plasma EUDAMED
Biophen Normal Control Plasma GUDID
Generic name
Multiple coagulation marker IVD, control
Model / Ref / Catalog
223201, Control Normal Plasma
Primary DI / UDI-DI
03663537008306
Basic UDI-DI
366353700034B6
510(k) Number
FDA product code
GGN
EMDN code
W0103020702 Control plasma for haemostasis
GMDN term
Multiple coagulation marker IVD, control
Device class
Class C EUDAMED
Class II GUDID
Regulation number
864.5425
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple coagulation factor IVD, control

Cleared under the same submission (K083729)

Similar devices in this category

Other devices filed under CONTROL PLASMA FOR HAEMOSTASIS.

Other devices from Hyphen Biomed

See all devices from Hyphen Biomed →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • New device
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)