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Accuniq Bc720
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ACCUNIQ BC720_CatalogModel ACCUNIQ BC720
Identity
- Trade Name
- ACCUNIQ BC720 EUDAMEDACCUNIQ FDA UDI
- Generic Name
- Bioelectrical body composition analyser FDA UDI
- Model / Reference
- ACCUNIQ BC720 EUDAMEDFDA UDIACCUNIQ BC720_Catalog EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08805116000119 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08805116000119 EUDAMED
- FDA Product Code
- PUH FDA UDI
- EMDN Code
- Z12099001 BODY IMPEDANCE ANALYSERS EUDAMED
- GMDN Term
- Bioelectrical body composition analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 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
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
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
Yes
FDA UDI
Accuniq Bc720 by SELVAS Healthcare, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08805116000119 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SELVAS Healthcare, Inc.
- EUDAMED SRN
- KR-MF-000019198
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 0815d71d-f3ee-435e-b159-781c429e7e66 61 fields · synced Jun 20, 2026
- FDA UDI 740a3c41-face-4f28-b393-af23e123cdf4 33 fields · synced May 30, 2026