Identity
- Trade Name
- Bolt EUDAMEDFDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Device Name
- Bolt EUDAMEDBolt EIA FDA UDI
- Model / Reference
- 00500 EUDAMEDFDA UDI
- Description
- Bolt EIA FDA UDI
Identifiers
- Catalog Number
- 00500 FDA UDI
- Primary DI / UDI-DI
- B350005000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B35000500BA EUDAMED
- Direct Marketing DI
- B350005000 EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 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
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
Bolt by Gold Standard Diagnostics, 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 | ++B35000500BA | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
- EUDAMED SRN
- US-MF-000027142
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a072fc3a-114e-4234-b03b-660a18fbfc2c 61 fields · synced Jun 8, 2026
- FDA UDI 83182835-4020-4661-b6b7-a6192db9b2a1 34 fields · synced May 30, 2026