Identity
- Trade Name
- CAPILLARYS 3 DBS MICROPLATES EUDAMEDFDA UDI
- Generic Name
- Microplate IVD FDA UDI
- Device Name
- CAPILLARYS 3 DBS MICROPLATES EUDAMEDMICROPLATES ARE AN ACCESSORY _PLASTIC PLATES FDA UDI
- Model / Reference
- 2578 EUDAMEDFDA UDI
- Description
- MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES FDA UDI
Identifiers
- Catalog Number
- 2578 FDA UDI
- Primary DI / UDI-DI
- 03607360025789 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607362578BUES EUDAMED
- 510(k) Number
- K232027 FDA UDI
- FDA Product Code
- GKA FDA UDI
- EMDN Code
- W050301020280 SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES EUDAMED
- GMDN Term
- Microplate IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7415 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Capillarys 3 Dbs Microplates by Sebia — 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 | 3607362578BUES | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED ed7ca2a1-7513-4a66-b2c5-9a5c9354a1b6 61 fields · synced Jun 18, 2026
- FDA UDI ff4a5226-c102-4788-853c-839f98b35cfa 36 fields · synced May 30, 2026