Identity
- Trade Name
- Endoscopic Light Source EUDAMED
- Device Name
- Endoscopic Light Source EUDAMED
- Model / Reference
- TLS-L900Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974439670230 EUDAMED
- Basic UDI-DI
- 6974439670209ER EUDAMED
- Direct Marketing DI
- 06974439670230 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Endoscopic Light Source by Nanjing Tuge Healthcare Co., Ltd. — Class I — 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 | 6974439670209ER | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Tuge Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000018925
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 239d6172-f98e-4023-93e0-95fe276c2ab9 61 fields · synced Oct 6, 2026