Identity
- Trade Name
- abioSCOPE EUDAMEDFDA UDI
- Generic Name
- Ultraviolet-visible spectrophotometer IVD FDA UDI
- Device Name
- abioSCOPE EUDAMEDThe abioSCOPE is a table top diagnostic device that measures analytes in biological samples, using testspecific capsules (IVD CAPSULE) intended for use with this instrument. FDA UDI
- Model / Reference
- P01.00007 EUDAMEDFDA UDI
- Description
- The abioSCOPE is a table top diagnostic device that measures analytes in biological samples, using testspecific capsules (IVD CAPSULE) intended for use with this instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996894014 EUDAMEDFDA UDI
- Basic UDI-DI
- 7649996894P01ANF EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
- GMDN Term
- Ultraviolet-visible spectrophotometer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Greece 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
abioSCOPE by Abionic SA — 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 | 7649996894P01ANF | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Abionic SA
- EUDAMED SRN
- CH-MF-000026307
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (2)
- EUDAMED f519bedf-7a39-4967-a920-056c50cc5b32 61 fields · synced Jul 12, 2026
- FDA UDI c5a3081e-c4e7-43e8-b3ea-6a7047f501c3 33 fields · synced May 30, 2026