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12mm X 75mm Primary Sample Tubs, Box Of 250
EUDAMEDFDA UDIClass A (EU MDR)
Ref 200220
Identity
- Trade Name
- 12mm X 75mm Primary Sample Tubs, Box Of 250 EUDAMEDAdvanced Instruments Cuvettes FDA UDI
- Generic Name
- Laboratory analyser cuvette IVD, single-use FDA UDI
- Device Name
- Specimen Receptacles EUDAMEDAdvanced Instruments cuvettes are used to facilitate sample management while using Advanced Instruments osmometers FDA UDI
- Model / Reference
- 200220 EUDAMEDFDA UDI
- Description
- Advanced Instruments cuvettes are used to facilitate sample management while using Advanced Instruments osmometers FDA UDI
Identifiers
- Catalog Number
- 200220 FDA UDI
- Primary DI / UDI-DI
- 00816068020627 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606802SPECRECEPDL EUDAMED
- FDA Product Code
- JJM FDA UDI
- EMDN Code
- W02069085 VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Laboratory analyser cuvette IVD, single-use 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
12mm X 75mm Primary Sample Tubs, Box Of 250 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 833f1075-44df-401b-8cdf-f83fd70c3a5c 61 fields · synced Jun 19, 2026
- FDA UDI ac3da7cf-9949-4887-8ea0-7d22a7dc3299 35 fields · synced May 25, 2026