Identity
- Device Name
- Softclip EUDAMED
- Model / Reference
- 534860 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04065803801038 EUDAMED
- Basic UDI-DI
- 4065803801GR12AAU2 EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES 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
Category: Pulmonary function testing filter/mouthpiece
Softclip by Geratherm Respiratory GmbH — 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 | 4065803801GR12AAU2 | Class I | Active |
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Manufacturer
- Manufacturer
- Geratherm Respiratory GmbH
- EUDAMED SRN
- DE-MF-000006818
Sources (1)
- EUDAMED 16f0f632-1cc1-4d63-8995-e60b2831883b 61 fields · synced Jun 19, 2026