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Single-Use Bronchoscope
EUDAMEDClass IIa (EU MDR)
Ref AE-B36Model Single-Use BronchoscopeRef AE-B84L
Identity
- Trade Name
- Single-Use Bronchoscope EUDAMED
- Device Name
- Single-Use Bronchoscope EUDAMED
- Model / Reference
- Single-Use Bronchoscope EUDAMEDAE-B36 EUDAMEDAE-B84L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127848728 EUDAMED06942127848827 EUDAMED
- Basic UDI-DI
- 697067138FB039C2 EUDAMED
- EMDN Code
- Z12020801 BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Bronchoscope by Alton (Shanghai) 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 | 697067138FB039C2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 88f2d924-2aa1-4f69-b9e5-7c240ee0df52 61 fields · synced Jul 14, 2026
- EUDAMED d7b5b67d-00cf-43cf-9b61-23adc97e75d8 61 fields · synced Jul 9, 2026