Identity
- Trade Name
- Disposable Sample Tubes EUDAMEDAdvanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes FDA UDI
- Generic Name
- Osmolality IVD, kit, freezing point FDA UDI
- Device Name
- Specimen Receptacles EUDAMEDSamples tubes for use with the OsmoPRO® Multi-Sample Micro-Osmometer FDA UDI
- Model / Reference
- 202825 EUDAMEDFDA UDI
- Description
- Samples tubes for use with the OsmoPRO® Multi-Sample Micro-Osmometer FDA UDI
Identifiers
- Catalog Number
- 202825 FDA UDI
- Primary DI / UDI-DI
- 00816068020849 EUDAMED00816068020573 FDA UDI
- Basic UDI-DI
- 081606802SPECRECEPDL EUDAMED
- FDA Product Code
- JJM FDA UDI
- EMDN Code
- W02069085 VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Osmolality IVD, kit, freezing point FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2730 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Sample Tubes by Advanced Instruments, LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081606802SPECRECEPDL | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Advanced Instruments, LLC
- EUDAMED SRN
- US-MF-000027205
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (2)
- EUDAMED 03542433-4031-4266-a214-f8527d99cd6f 61 fields · synced Aug 4, 2026
- FDA UDI 94ed8132-381b-46a2-8956-8daf774e97a3 35 fields · synced May 30, 2026