← Back to catalogue
Vapro Vapor Pressure Osmometer
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref Model 5600
Identity
- Trade Name
- Vapro Vapor Pressure Osmometer EUDAMEDVapro® Vapor Pressure Osmometer FDA UDI
- Generic Name
- Osmometric analyser IVD FDA UDI
- Device Name
- Vapro Vapor Pressure Osmometer EUDAMEDThe Vapro is a bench-top in-vitro diagnostic laboratory instrument for use by trained technical personnel to determine the osmolality concentration of a water based solution by means of the dew point temperature depression of a specimen sample. FDA UDI
- Model / Reference
- Model 5600 EUDAMEDFDA UDI
- Description
- The Vapro is a bench-top in-vitro diagnostic laboratory instrument for use by trained technical personnel to determine the osmolality concentration of a water based solution by means of the dew point temperature depression of a specimen sample. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540303425 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661540303425 EUDAMED
- FDA Product Code
- JNA FDA UDI
- EMDN Code
- W02079017 OSMOMETERS EUDAMED
- GMDN Term
- Osmometric analyser IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vapro Vapor Pressure Osmometer 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-03661540303425 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED a0c4f29e-66cc-4306-bebc-e8190a3f6592 61 fields · synced Jul 15, 2026
- FDA UDI 534c9298-3a53-4858-85de-177b99cdbfbb 34 fields · synced May 30, 2026