Identity
- Device Name
- Exercisers, Respiratory EUDAMED
- Model / Reference
- 2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973696790323 EUDAMED
- Basic UDI-DI
- 6973696791HX2101RA EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Pulmonary function analysis system, adult
Exercisers, Respiratory by Ningbo Hscc Medicaltechnology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6973696791HX2101RA | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Hscc Medicaltechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000046955
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED ae0462b9-5aa2-4610-b958-c6b89254cea4 61 fields · synced Jun 18, 2026