Identity
- Trade Name
- Electric Bronchoscope EUDAMED
- Device Name
- Electric Bronchoscope EUDAMED
- Model / Reference
- E4000 EUDAMEDE2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429024005 EUDAMED06945429023985 EUDAMED
- Basic UDI-DI
- 69454290EB001H4 EUDAMED
- Direct Marketing DI
- 06945429024005 EUDAMED06945429023985 EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Electric Bronchoscope by Shenzhen Comen Medical Instruments Co., LTD. — 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 | 69454290EB001H4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7378e1c5-63ca-4c68-b2b0-3d3a556c9ede 61 fields · synced Oct 6, 2026
- EUDAMED d506223e-becc-4fc2-8d28-c57b88a01859 61 fields · synced May 18, 2026