Multichem NB NB800X
Ref NB800X
Multichem NB NB800X is a device classified as Class C in the EU and Class I in the US made by Techno-Path Manufacturing, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 539152344CHEM065K) and listed in FDA GUDID since 16 Sep 2022 (UDI-DI 05391523440110), active as of 23 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number539152344CHEM065K 05391523440110 | Date10 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05391523440110 | Date16 Sep 2022 | StatusListed |
Official records
- EUDAMED public site 539152344CHEM065K
- AccessGUDID record 05391523440110
Across registries
- EUDAMED Basic UDI-DI 539152344CHEM065K registered 10 Aug 2026 Active
- FDA GUDID UDI-DI 05391523440110 listed 16 Sep 2022 Listed
Timeline
- Listed FDA GUDID 05391523440110
- Registered EUDAMED 539152344CHEM065K
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Multichem NB
- Generic name
- Multiple-type clinical chemistry analyte profile IVD, control
- Model / Ref / Catalog
- NB800X
- Primary DI / UDI-DI
- 05391523440110
- Basic UDI-DI
- 539152344CHEM065K
- FDA product code
- JJY, OHQ
- EMDN code
- W0101050102 Unassayed multicomponent controls (cc)
- GMDN term
- Multiple-type clinical chemistry analyte profile IVD, control
- Device class
- Class C EUDAMEDClass I GUDID
- Regulation number
- 862.1660
- EU registration type
- Standard device
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class C | Class I |
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