Identity
- Trade Name
- NeoLumax CLIA Analyzer FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- NeoLumax® CLIA Analyzer EUDAMED
- Model / Reference
- IN010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- IN010 FDA UDI
- Primary DI / UDI-DI
- 00816870020006 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687002IN010ZK EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 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
NeoLumax® CLIA Analyzer 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 | 081687002IN010ZK | 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 dc3eb795-baae-4419-8a4c-04df4e3dd196 61 fields · synced Jun 19, 2026
- FDA UDI 309e30c2-91da-40ad-9fd1-b6d38a73b59a 34 fields · synced May 29, 2026