Multichem U 09339868190
Part of a family of 8 devices: see the family page
Ref 09339868190
Multichem U 09339868190 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 539152344CHEM045F) and listed in FDA GUDID since 16 Sep 2022 (UDI-DI 05391523442053), active as of 25 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 | Number539152344CHEM045F 05391523442053 | Date10 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05391523442053 | Date16 Sep 2022 | StatusListed |
Official records
- EUDAMED public site 539152344CHEM045F
- AccessGUDID record 05391523442053
Across registries
- EUDAMED Basic UDI-DI 539152344CHEM045F registered 10 Aug 2026 Active
- FDA GUDID UDI-DI 05391523442053 listed 16 Sep 2022 Listed
Timeline
- Listed FDA GUDID 05391523442053
- Registered EUDAMED 539152344CHEM045F
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Multichem U
- Generic name
- Multiple-type clinical chemistry analyte profile IVD, control
- Model / reference
- 09339868190
- Primary DI / UDI-DI
- 05391523442053
- Basic UDI-DI
- 539152344CHEM045F
- FDA product code
- JJY, OHQ
- EMDN code
- W0101050101 Assayed 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 |
Similar devices in this category
Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).
- uTrol High 981822 by Thermo Fisher Scientific Oy
- Eurotrol epoc GAS-ISE Metabolites Level 3 266.003.010 by Eurotrol B.V.
- Assayed Multiple Chemistry Control (Multi-QC) ECH0192501 by Maccura Biotechnology Co., Ltd.
- Miris Check™ 39-01-003 by Miris AB
- ABX Pentra P MultiControl 1300054415 by Horiba Abx
- Abtrol 981044 by Thermo Fisher Scientific Oy
- VALIDATE® CHEM 17 Test Set 1700 by LGC Clinical Diagnostics, Inc.
- BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) BG5002 by Randox Laboratories, Ltd.
- RNA QC 253 Multi-Level by Rna Medical Division
- VALIDATE® GC3 Test Set 1300ab by LGC Clinical Diagnostics, Inc.