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Single-use Flexible Video Bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref DBRS2-221PModel DBRS2-001P, DBRS2-121P, DBRS2-221P, DBRS2-301P, DBRS2-222HP, DBRS2-302HP, DBRS2-122HP, DBRS2-223HP, DBRS2-303HP, DBRS2-123HPRef DBRS2-303HPRef DBRS2-301PRef DBRS2-223HPRef DBRS-100HLPRef DBRS2-001PRef DBRS2-123HPRef DBRS2-121P
Identity
- Trade Name
- Single-use Flexible Video Bronchoscope EUDAMED
- Device Name
- Single-Use Flexible Video Bronchoscope EUDAMED
- Model / Reference
- DBRS2-001P, DBRS2-121P, DBRS2-221P, DBRS2-301P, DBRS2-222HP, DBRS2-302HP, DBRS2-122HP, DBRS2-223HP, DBRS2-303HP, DBRS2-123HP EUDAMEDDBRS2-221P EUDAMEDDBRS2-303HP EUDAMEDDBRS2-301P EUDAMEDDBRS2-223HP EUDAMEDDBRS-100HLP EUDAMEDDBRS2-001P EUDAMEDDBRS2-123HP EUDAMEDDBRS2-121P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235401274 EUDAMED06974235401212 EUDAMED06974235401281 EUDAMED06974235401144 EUDAMED06974235401069 EUDAMED06974235401250 EUDAMED06974235401229 EUDAMED06974235401267 EUDAMED
- Basic UDI-DI
- 697423540DBRS2FZ EUDAMED697423540DBRSK5 EUDAMED
- Direct Marketing DI
- 06974235401144 EUDAMED06974235401069 EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-use Flexible Video Bronchoscope by Himaging Technology (Shanghai) 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 | 697423540DBRS2FZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Himaging Technology (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000028002
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (8)
- EUDAMED cb77114f-117f-4fd8-890d-83c3918c7964 61 fields · synced Aug 1, 2026
- EUDAMED 7de165e1-3be6-4991-9d08-a9507ca40398 61 fields · synced May 16, 2026
- EUDAMED 165ec896-1edb-4d99-97c9-781d362061e2 61 fields · synced May 17, 2026
- EUDAMED e93505c1-9a8e-4a6c-bfb0-9f834a2504ed 61 fields · synced May 17, 2026
- EUDAMED 35bfb6e8-f27c-45ac-874c-3f7a8fe141c8 61 fields · synced May 18, 2026
- EUDAMED 5b0af7c4-bc5b-44b7-ad07-7c92387e20b6 61 fields · synced May 18, 2026
- EUDAMED 797a49ca-be2e-414c-9dc3-5e5106f8bb3b 61 fields · synced May 18, 2026
- EUDAMED c73bbb35-f11a-42b4-9e49-b290f33cad80 61 fields · synced May 19, 2026