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Respiratory Effort Piezo Sensor -Kit-Medatec Design
EUDAMEDClass I (EU MDR)
Ref 601012Model 13XX, 612XX series
by S.L.P. Ltd.
Identity
- Trade Name
- Respiratory Effort Piezo Sensor -Kit-Medatec Design EUDAMED
- Device Name
- Effort Sensors EUDAMED
- Model / Reference
- 13XX, 612XX series EUDAMED601012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016715484 EUDAMED
- Basic UDI-DI
- 7290008986EF001VK EUDAMED
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER 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
Respiratory Effort Piezo Sensor -Kit-Medatec Design by S.L.P. 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 | 7290008986EF001VK | Class I | Active |
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Manufacturer
- Manufacturer
- S.L.P. Ltd.
- EUDAMED SRN
- IL-MF-000016600
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED 3a35e379-0585-45d0-ad83-088d6711c935 61 fields · synced Jul 9, 2026