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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref 112000101Model VG55、VG65Ref 112000363Ref 112000140Ref 112000325Model VG50
Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- VG55、VG65 EUDAMED112000101 EUDAMED112000363 EUDAMED112000140 EUDAMEDVG50 EUDAMED112000325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972733991013 EUDAMED06972733991037 EUDAMED06972733991402 EUDAMED06972733991945 EUDAMED
- Basic UDI-DI
- 697273399030105NIV6X EUDAMED697273399120301PVSIJG EUDAMED
- Direct Marketing DI
- 06972733991013 EUDAMED06972733991037 EUDAMED06972733991402 EUDAMED06972733991945 EUDAMED
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMEDZ12030104 PORTABLE PULMONARY VENTILATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 HEYER Medical Co., Ltd. — Class IIb — 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 | 697273399030105NIV6X | Class IIb | Active |
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Manufacturer
- Manufacturer
- HEYER Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014712
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 19558ff6-7f9c-4c03-bb83-7e534609be6d 61 fields · synced Jul 22, 2026
- EUDAMED 3d5e3103-4304-469e-b79e-00e7073a875f 61 fields · synced May 18, 2026
- EUDAMED 464c26fe-5406-463b-afa0-de33ca983262 61 fields · synced May 18, 2026
- EUDAMED b51ecd84-2c4c-4d4a-b156-8a4d611f5714 61 fields · synced May 18, 2026