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Spirometer
EUDAMEDClass IIa (EU MDR)
Ref /Model VC-30, VC-30A, VC-30T, VC-30 PRO
Identity
- Device Name
- Spirometer EUDAMED
- Model / Reference
- VC-30, VC-30A, VC-30T, VC-30 PRO EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604663 EUDAMED
- Basic UDI-DI
- 69268026SP0300000000001TR EUDAMED
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Spirometer by Medcaptain 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 | 69268026SP0300000000001TR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ebac3907-1e7c-4749-87bc-97388c3df6b5 61 fields · synced Jul 23, 2026