Identity
- Trade Name
- Hermia EUDAMED
- Device Name
- Affinity EUDAMED
- Model / Reference
- 00859873006233 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00859873006233 EUDAMED
- Basic UDI-DI
- 08598730060056G EUDAMED
- EMDN Code
- Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
Hermia by Hermes Medical Solutions AB — Class IIb — 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 | 08598730060056G | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
- EUDAMED SRN
- SE-MF-000023032
Sources (1)
- EUDAMED 61cd9d8b-ec7f-46fd-a144-832ee9299f1e 61 fields · synced Jun 17, 2026