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Pras Eya

by Anaerobe Systems

Part of a family of 132 devices: see the family page

Ref AS-511

Pras Eya (AS-511) is a device classified as Class A in the EU and Class I in the US made by Anaerobe Systems, registered in EUDAMED on 17 Jul 2025 (Basic UDI-DI 081004890ANAEROBEDT) and listed in FDA GUDID since 1 May 2020 (UDI-DI 00810048900206), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081004890ANAEROBEDT Basic UDI-DI 00810048900206UDI-DIDate17 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810048900206 UDI-DI Date1 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004890ANAEROBEDT registered 17 Jul 2025 Active
  • FDA GUDID UDI-DI 00810048900206 listed 1 May 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00810048900206
  2. Registered EUDAMED 081004890ANAEROBEDT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pras Eya EUDAMED
PRAS Egg Yolk Agar (EYA) GUDID
Generic name
Differential/selective agar culture medium IVD
Device name
Anaerobic Culture Media
Model / Ref / Catalog
AS-511
Primary DI / UDI-DI
00810048900206
Basic UDI-DI
081004890ANAEROBEDT
FDA product code
JSH
EMDN code
W0104010405 Non-chromogenic media (plates)
GMDN term
Differential/selective agar culture medium IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
866.2320
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000040030
Authorised representative
Casus Europe B.V. NL-AR-000037688

Similar devices in this category

Other devices filed under NON-CHROMOGENIC MEDIA (PLATES).

Other devices from Anaerobe Systems

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Properties

  • Single use
  • Contains animal tissues or cells
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)