Identity
- Device Name
- Breathing Exerciser (Spirometer) EUDAMED
- Model / Reference
- TDBE-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977793990044 EUDAMED
- Basic UDI-DI
- 697779399SZTD004RL EUDAMED
- EMDN Code
- Z12150199 SPIROMETRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Breathing Exerciser (Spirometer) by Suzhou Tedamed 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 | 697779399SZTD004RL | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Tedamed Co., Ltd
- EUDAMED SRN
- CN-MF-000043696
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7b6fa625-1dc0-4d95-a5b2-6ab17692b7ba 61 fields · synced Aug 2, 2026