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Optimole Osmolality Standard 290 mmol/kg
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref OA-029
Identity
- Trade Name
- OPTIMOLE™ Osmolality Standard, 290 mmol/kg, 60x.4mL FDA UDI
- Generic Name
- Osmolality IVD, calibrator FDA UDI
- Device Name
- Optimole Osmolality Standard 290 mmol/kg EUDAMEDELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer. FDA UDI
- Model / Reference
- OA-029 EUDAMEDOA-290 FDA UDI
- Description
- ELITechGroup's Opti-Mole solution is for calibration of the Vapro Vapor Pressure Osmometer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540301490 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540301490 EUDAMED
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Osmolality IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Optimole Osmolality Standard 290 mmol/kg by Elitechgroup Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03661540301490 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 40384ed5-2ca0-4330-ab05-b6f36d896327 61 fields · synced Jun 18, 2026
- FDA UDI d51d46f3-6c71-49a3-94f1-8ec8cd4edac1 35 fields · synced May 30, 2026