Identity
- Trade Name
- Sample Tubes & Probe Wipes, 1x250 EUDAMEDAdvanced Instruments Fiske 210 Single-Sample Micro-Osmometer Sample Tubes, Box FDA UDI
- Generic Name
- Osmolality IVD, kit, freezing point FDA UDI
- Device Name
- Specimen Receptacles EUDAMEDSample tubes and cleaners for use with the Fiske™ 210 Single-Sample Micro-Osmometer FDA UDI
- Model / Reference
- 110825 EUDAMEDFDA UDI
- Description
- Sample tubes and cleaners for use with the Fiske™ 210 Single-Sample Micro-Osmometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816068020818 EUDAMEDFDA 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
Sample Tubes & Probe Wipes, 1x250 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 90811377-1c71-4e2c-858f-f04ffeced996 61 fields · synced Jun 18, 2026
- FDA UDI 18eaf7b7-5efc-45cb-b4df-22d2f87a8df7 34 fields · synced May 30, 2026