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Spirometer(Breathing exerciser)
EUDAMEDClass I (EU MDR)
Ref A-2 600/900/1200ccRef C Dial wheel typeRef D Knob typeRef A-3 600/900/1200ccRef B 5000mlRef A-1 600/900/1200ccRef A-2 700/130/1900ccRef B 3000mlRef B 4000mlRef A-1 700/130/1900cc
Identity
- Trade Name
- Spirometer(Breathing exerciser) EUDAMED
- Device Name
- Spirometer(Breathing exerciser) EUDAMED
- Model / Reference
- A-2 600/900/1200cc EUDAMEDC Dial wheel type EUDAMEDD Knob type EUDAMEDA-3 600/900/1200cc EUDAMEDB 5000ml EUDAMEDA-1 600/900/1200cc EUDAMEDA-2 700/130/1900cc EUDAMEDB 3000ml EUDAMEDB 4000ml EUDAMEDA-1 700/130/1900cc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971486642760 EUDAMED06971486642838 EUDAMED06971486642845 EUDAMED06971486642784 EUDAMED06971486642821 EUDAMED06971486642746 EUDAMED06971486642777 EUDAMED06971486642807 EUDAMED06971486642814 EUDAMED06971486642753 EUDAMED
- Basic UDI-DI
- 6971486640278CY EUDAMED
- Direct Marketing DI
- 06971486642760 EUDAMED06971486642838 EUDAMED06971486642845 EUDAMED06971486642784 EUDAMED06971486642821 EUDAMED06971486642746 EUDAMED06971486642777 EUDAMED06971486642807 EUDAMED06971486642814 EUDAMED06971486642753 EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spirometer(Breathing exerciser) by Shaoxing Reborn Medical Devices Co., Ltd. — Class I — 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 | 6971486640278CY | Class I | Active |
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Manufacturer
- Manufacturer
- Shaoxing Reborn Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000016475
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (10)
- EUDAMED 0698e3a9-66f4-484c-b725-5e30cc86b732 61 fields · synced Oct 6, 2026
- EUDAMED c784a509-22e0-4215-add4-e09f7bb452e3 61 fields · synced May 17, 2026
- EUDAMED ce608f75-1e11-4c09-88c2-220b44761e0d 61 fields · synced May 17, 2026
- EUDAMED a607fc16-a38e-4d06-aecf-bd062aa103c3 61 fields · synced May 17, 2026
- EUDAMED c8ec58f4-476f-43ea-af93-ffffad6ddd62 61 fields · synced May 18, 2026
- EUDAMED 7a011da7-da6c-48a0-a526-8d38f3d219fe 61 fields · synced May 18, 2026
- EUDAMED 9022aef8-73fe-41ef-9789-271f337693b0 61 fields · synced May 18, 2026
- EUDAMED 12382468-2028-4d4e-b62e-476fc6b228fc 61 fields · synced May 18, 2026
- EUDAMED 0e479605-5f72-4328-b1cc-ec43705ca387 61 fields · synced May 18, 2026
- EUDAMED 72eefaf7-ea9c-4e85-9275-d9200a7a0e72 61 fields · synced May 18, 2026