Identity
- Device Name
- Hermes EUDAMED
- Model / Reference
- Hermes EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B816HMS0 EUDAMED
- Basic UDI-DI
- ++B816HMSSG EUDAMED
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Full-body CT system
Hermes by Optellum Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++B816HMSSG | Class I | Active |
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Manufacturer
- Manufacturer
- Optellum Ltd
- EUDAMED SRN
- GB-MF-000002862
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bc2673d2-b83e-4672-b09e-018fb915cbaf 61 fields · synced Jun 20, 2026