Identity
- Trade Name
- BODYGRAM HBO EUDAMED
- Device Name
- BODYGRAM SOFTWARE EUDAMED
- Model / Reference
- SWHBO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80515774700958 EUDAMED
- Basic UDI-DI
- 805157747BODYGRAM7Q EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bodygram Hbo by Akern Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805157747BODYGRAM7Q | Class I | Active |
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Manufacturer
- Manufacturer
- Akern Srl
- EUDAMED SRN
- IT-MF-000013092
Sources (1)
- EUDAMED 55c3651a-2615-4850-9534-a7c18df6e221 61 fields · synced Jul 30, 2026