Identity
- Trade Name
- FORA IR20 Ear Thermometer Probe Cover EUDAMED
- Device Name
- Probe Cover EUDAMED
- Model / Reference
- ACS034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640143651788 EUDAMED
- Basic UDI-DI
- 01436501550000AP EUDAMED
- Unit of Use DI
- 07640402710683 EUDAMED
- EMDN Code
- V030180 BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES 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
FORA IR20 Ear Thermometer Probe Cover by ForaCare Suisse AG — 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 | 01436501550000AP | Class I | Active |
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Manufacturer
- Manufacturer
- ForaCare Suisse AG
- EUDAMED SRN
- CH-MF-000019906
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cf75c023-9fab-45e1-b2a8-0c82863c04b8 61 fields · synced Jun 17, 2026