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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref 112000103Model Shangrila510SRef 112000080Model VG70Ref 112000143Ref 112000142Ref 112000086
Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- Shangrila510S EUDAMED112000103 EUDAMEDVG70 EUDAMED112000080 EUDAMED112000143 EUDAMED112000142 EUDAMED112000086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946473201336 EUDAMED06946473208021 EUDAMED06946473201435 EUDAMED06946473201428 EUDAMED06946473208632 EUDAMED
- Basic UDI-DI
- B-06946473201336 EUDAMED69464732030105ICVSB EUDAMEDB-06946473201435 EUDAMEDB-06946473201428 EUDAMEDB-06946473208632 EUDAMED
- Direct Marketing DI
- 06946473208021 EUDAMED
- EMDN Code
- Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMEDZ1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDRomania 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ventilator by Beijing Aeonmed Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06946473201336 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-06946473201336 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Aeonmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000014714
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED c6b7921a-0118-4fcb-be55-b1e271fde82f 61 fields · synced Jul 14, 2026
- EUDAMED 8306b62c-d792-48c8-a2ed-4801b72dc7b1 61 fields · synced May 16, 2026
- EUDAMED 53ec3c74-ea77-4423-baac-44a127da2fa0 61 fields · synced May 17, 2026
- EUDAMED 524833d5-db08-4ad3-9ba3-284b12dadf8a 61 fields · synced May 17, 2026
- EUDAMED 58156dd1-3199-4116-a7b0-e5eed06fb12c 61 fields · synced May 18, 2026