Identity
- Device Name
- DIGITAL-HAND NW EUDAMED
- Model / Reference
- DIGITAL-HAND NW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800016000122 EUDAMED
- Basic UDI-DI
- 8800016000003SG EUDAMED
- EMDN Code
- A019016 BRACHYTHERAPY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Digital-Hand Nw by Bomtech — Class IIa — 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 | 8800016000003SG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bomtech
- EUDAMED SRN
- KR-MF-000037151
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c8b64413-b51f-4099-9816-36bb4a39ea47 61 fields · synced Jul 11, 2026