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Lower Gastrointestinal Video Endoscope
EUDAMEDClass IIa (EU MDR)
Ref EC-A20PModel EC-300LRef EC-300PRef EC-A30PLRef EC-A20PLRef EC-A30PRef EC-300TRef EC-201Model EC-200Ref EC-200LRef EC-A20L
Identity
- Trade Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Device Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Model / Reference
- EC-300L EUDAMEDEC-A20P EUDAMEDEC-300P EUDAMEDEC-A30PL EUDAMEDEC-A20PL EUDAMEDEC-A30P EUDAMEDEC-300T EUDAMEDEC-200 EUDAMEDEC-201 EUDAMEDEC-200L EUDAMEDEC-A20L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429061390 EUDAMED06945429060348 EUDAMED06945429060379 EUDAMED06945429061406 EUDAMED06945429060362 EUDAMED06945429060386 EUDAMED06945429028652 EUDAMED06945429028645 EUDAMED06945429028638 EUDAMED06945429061383 EUDAMED
- Basic UDI-DI
- 69454290LG001LL EUDAMED69454290VE002PN EUDAMED
- Direct Marketing DI
- 06945429061390 EUDAMED06945429060348 EUDAMED06945429060379 EUDAMED06945429061406 EUDAMED06945429060362 EUDAMED06945429060386 EUDAMED06945429028652 EUDAMED06945429028645 EUDAMED06945429028638 EUDAMED06945429061383 EUDAMED
- EMDN Code
- Z12020606 VIDEO COLONOSCOPES 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
Lower Gastrointestinal Video Endoscope 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 | 69454290LG001LL | 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 (10)
- EUDAMED c75198cf-05d5-435a-b02a-4ef1dc4f4731 61 fields · synced Oct 6, 2026
- EUDAMED 29f85fb8-a697-4e0f-bf51-f633689d84c8 61 fields · synced May 16, 2026
- EUDAMED f6e6451a-daa1-49a1-86f2-132bf0439c97 61 fields · synced May 16, 2026
- EUDAMED 47821dd1-f658-4047-9a8a-d39993be8556 61 fields · synced May 18, 2026
- EUDAMED 4f108530-92b4-4b48-b025-5d4f1c32ae1c 61 fields · synced May 18, 2026
- EUDAMED 1e475b21-52bc-40b8-98b3-fde18875602a 61 fields · synced May 18, 2026
- EUDAMED 1ac156be-3769-4fb9-adb3-a739c3bdb00f 61 fields · synced May 19, 2026
- EUDAMED 32225725-441f-4e1c-bb73-2363ac8b08ab 61 fields · synced May 19, 2026
- EUDAMED d2fa8dcd-2688-40aa-ad5a-12fc92a29392 61 fields · synced May 19, 2026
- EUDAMED 53b7bfe0-3dba-4f2b-9ee8-583cdd15d42f 61 fields · synced May 19, 2026