Identity
- Trade Name
- TOP Lesion Generator TLG-10 EUDAMED
- Device Name
- TOP Lesion Generator EUDAMED
- Model / Reference
- TLG-10L EUDAMEDE60039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04996404600396 EUDAMED
- Basic UDI-DI
- B-04996404600396 EUDAMED
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TOP Lesion Generator TLG-10 by TOP Corporation — 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-04996404600396 | Class IIb | Active |
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Manufacturer
- Manufacturer
- TOP Corporation
- EUDAMED SRN
- JP-MF-000011618
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 75330ff9-00e0-4ac5-8097-17a6b4a69963 61 fields · synced Sep 17, 2026