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BioArray Array Imaging System TM (AIS) 400D
EUDAMEDFDA UDIClass A (EU MDR)
Ref 790-20016Model 400D
Identity
- Trade Name
- BioArray Array Imaging System TM (AIS) 400D EUDAMEDBioArray Assay Imaging System TM (AIS) 400D FDA UDI
- Generic Name
- Microarray analyser IVD, semi-automated FDA UDI
- Device Name
- Array Imaging System (AIS) EUDAMED
- Model / Reference
- 400D EUDAMED790-20016 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 790-20016 FDA UDI
- Primary DI / UDI-DI
- 10888234102229 EUDAMEDFDA UDI
- Basic UDI-DI
- 088823479020016PM EUDAMED
- Direct Marketing DI
- 10888234102229 EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050201 MICRO-ARRAY ANALYSERS EUDAMED
- GMDN Term
- Microarray analyser IVD, semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
BioArray Array Imaging System TM (AIS) 400D by Bioarray Solutions Ltd — 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 | 088823479020016PM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- BioArray Solutions Ltd
- EUDAMED SRN
- US-MF-000022068
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 8738be90-56d4-4b02-979f-2c9f31e00441 61 fields · synced Jul 14, 2026
- FDA UDI 31a115cc-62d2-410b-85f7-3c78f0bd7c08 35 fields · synced May 30, 2026