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Mdh
EUDAMEDClass IIa (EU MDR)
Ref MB5128 (Standard Deflection; English)Model MB5128, MB4222
Identity
- Trade Name
- MDH EUDAMED
- Device Name
- MDH Flexible Video Bronchoscope EUDAMED
- Model / Reference
- MB5128, MB4222 EUDAMEDMB5128 (Standard Deflection; English) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176281101 EUDAMED
- Basic UDI-DI
- 697117628IDW EUDAMED
- Direct Marketing DI
- 06971176281101 EUDAMED
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Cyprus 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
Mdh by Zhuhai Pusen Medical Technology 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 | 697117628IDW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009220
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e07be928-25a8-4eca-a7ff-e41366d7d9be-1 61 fields · synced Jul 20, 2026
- EUDAMED e07be928-25a8-4eca-a7ff-e41366d7d9be-2 61 fields · synced Jul 20, 2026