Identity
- Trade Name
- BOMTECH EUDAMED
- Device Name
- RF COMBO JECTOR EUDAMED
- Model / Reference
- RF COMBO JECTOR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800016000368 EUDAMED
- Basic UDI-DI
- B-08800016000368 EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bomtech by Bomtech — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800016000368 | Class IIb | 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 99a2b933-406b-4bb5-a5ce-fb1c994394fa 61 fields · synced May 23, 2026