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Reusable Skin Temperature Probe
EUDAMEDClass IIb (EU MDR)
Ref FMT400/AS/MND-A15
by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- Reusable Skin Temperature Probe EUDAMED
- Device Name
- Non-Sterile Medical Temperature Probe EUDAMED
- Model / Reference
- FMT400/AS/MND-A15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698870355386 EUDAMED
- Basic UDI-DI
- B-08698870355386 EUDAMED
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose patient temperature probe, reusable
Reusable Skin Temperature Probe by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ — Class IIb — MDD — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08698870355386 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022486
Sources (1)
- EUDAMED 5ad92d90-3582-4605-9a46-ebb0eb892915 61 fields · synced Jun 19, 2026