Pras Choc
Part of a family of 132 devices: see the family page
Ref AS-214
Pras Choc (AS-214) 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 00810048900152), active as of 22 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not checked
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number081004890ANAEROBEDT 00810048900152 | Date17 Jul 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00810048900152 | Date1 May 2020 | StatusListed |
Official records
- EUDAMED public site 081004890ANAEROBEDT
- AccessGUDID record 00810048900152
Across registries
- EUDAMED Basic UDI-DI 081004890ANAEROBEDT registered 17 Jul 2025 Active
- FDA GUDID UDI-DI 00810048900152 listed 1 May 2020 Listed
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Timeline
- Listed FDA GUDID 00810048900152
- Registered EUDAMED 081004890ANAEROBEDT
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Pras Choc EUDAMEDPRAS Chocolate Agar (CHOC) GUDID
- Generic name
- Enriched agar culture medium IVD
- Device name
- Anaerobic Culture Media
- Model / Ref / Catalog
- AS-214
- Primary DI / UDI-DI
- 00810048900152
- Basic UDI-DI
- 081004890ANAEROBEDT
- FDA product code
- KZI
- EMDN code
- W0104010405 Non-chromogenic media (plates)
- GMDN term
- Enriched agar culture medium IVD
- Device class
- Class A EUDAMEDClass I GUDID
- Regulation number
- 866.2330
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000040030
- Authorised representative
- Casus Europe B.V. NL-AR-000037688
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