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Osmocoll HNL Osmolality Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref SS-273
Identity
- Trade Name
- OSMOCOLL® HNL osmolality Controls, 6x1mL FDA UDI
- Generic Name
- Osmolality IVD, control FDA UDI
- Device Name
- Osmocoll HNL Osmolality Controls EUDAMEDOsmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer. FDA UDI
- Model / Reference
- SS-273 EUDAMEDFDA UDI
- Description
- Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540300196 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540300196 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER EUDAMED
- GMDN Term
- Osmolality IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
Osmocoll HNL Osmolality Controls 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-03661540300196 | 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 33fea4f8-0465-4e39-abbd-84cff905f056 61 fields · synced Aug 2, 2026
- FDA UDI b552b1ff-7aef-42a2-bf9c-87c8e39d336a 35 fields · synced May 30, 2026