Identity
- Trade Name
- Monobind EUDAMEDImmunoassay Plate Washer FDA UDI
- Generic Name
- Microplate washer IVD FDA UDI
- Device Name
- PlateWash – Immunoassay Washer EUDAMED
- Model / Reference
- IN002 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- IN002 FDA UDI
- Primary DI / UDI-DI
- 00816870020044 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687002IN002ZL EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W02079080 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Microplate washer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
Monobind by Monobind, Inc. — 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 | 081687002IN002ZL | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Monobind Inc.
- EUDAMED SRN
- US-MF-000021611
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 73fc1771-a589-452b-9032-938939f3c8fa 61 fields · synced May 30, 2026
- FDA UDI 0595f844-67c2-4e9e-82cd-ea5bebd121ed 34 fields · synced May 30, 2026