Identity
- Trade Name
- Ease-Eject Sampler EUDAMEDAdvanced Instruments Ease-Eject 20-Microliter Sampler FDA UDI
- Generic Name
- Mechanical pipette FDA UDI
- Device Name
- Osmometer Accessories EUDAMEDAdvanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or Advanced Instruments OsmoTECH® Single-Sample Micro-Osmometer FDA UDI
- Model / Reference
- 3M0825 EUDAMEDFDA UDI
- Description
- Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or Advanced Instruments OsmoTECH® Single-Sample Micro-Osmometer FDA UDI
Identifiers
- Catalog Number
- 3M0825 FDA UDI
- Primary DI / UDI-DI
- 00816068020504 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606802OSMOACCSY5 EUDAMED
- FDA Product Code
- JJM FDA UDI
- EMDN Code
- W0503020199 PIPETTES - OTHER EUDAMED
- GMDN Term
- Mechanical pipette 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ease-Eject Sampler 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 | 081606802OSMOACCSY5 | 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 325d741e-2915-4725-9710-70f250b7fac9 61 fields · synced Jun 20, 2026
- FDA UDI 74ef5e04-c25d-4071-bf75-a19294e9aa6c 35 fields · synced May 30, 2026