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Seesheen
EUDAMEDClass IIa (EU MDR)
Ref BR-E14PFModel BR-E14PF、BR-E14PF plus、BR-E14PT、BR-E14PT plus、BR-E14F、BR-E14F plus、BR-E14H、BR-E14H plus、BR-E14HT、BR-E14HT plus、BR-E14HTB、BR-E14HTB plus、BR-E14TB、BR-E14TB plus
Identity
- Trade Name
- SEESHEEN EUDAMED
- Device Name
- Flexible Video Bronchoscope EUDAMED
- Model / Reference
- BR-E14PF、BR-E14PF plus、BR-E14PT、BR-E14PT plus、BR-E14F、BR-E14F plus、BR-E14H、BR-E14H plus、BR-E14HT、BR-E14HT plus、BR-E14HTB、BR-E14HTB plus、BR-E14TB、BR-E14TB plus EUDAMEDBR-E14PF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970680131674 EUDAMED
- Basic UDI-DI
- 69706801330BRAS EUDAMED
- Direct Marketing DI
- 06970680131674 EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Seesheen by Zhuhai Seesheen Medical Technology Co., Ltd. — Class IIa — CE/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 | 69706801330BRAS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Seesheen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027274
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a7ba2cfa-0d7a-46cf-ad68-dac2d204a101 61 fields · synced Oct 7, 2026