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Pipette Tips with Graduations 5-200 μL
EUDAMEDFDA UDIClass A (EU MDR)
Ref 800097
Identity
- Trade Name
- Pipette Tips with Graduations 5-200 μL EUDAMEDAdvanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene FDA UDI
- Generic Name
- Pipette tip FDA UDI
- Device Name
- Osmometer Accessories EUDAMEDContains 960 1-200µL pipette tips FDA UDI
- Model / Reference
- 800097 EUDAMEDFDA UDI
- Description
- Contains 960 1-200µL pipette tips FDA UDI
Identifiers
- Catalog Number
- 800097 FDA UDI
- Primary DI / UDI-DI
- 10816068020174 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606802OSMOACCSY5 EUDAMED
- 510(k) Number
- K152776 FDA UDI
- FDA Product Code
- GKL FDA UDI
- EMDN Code
- W0503020199 PIPETTES - OTHER EUDAMED
- GMDN Term
- Pipette tip FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5200 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pipette Tips with Graduations 5-200 μL 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 9aa65ca1-d16d-410c-9aab-0eb8be3c7425 61 fields · synced Jun 18, 2026
- FDA UDI 96de369a-4001-487f-bc8b-289b6b6ceb81 36 fields · synced May 30, 2026