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Reusable Incubator Skin Temperature Probe
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref FMT-INC/SISRef FMT-INC/SND3Ref FMT-INC/MDPRef FMT-INC/SRSRef FMT-INC/SNDRef FMT-INC/SFPRef FMT-INC/SO2Ref FMT-INC/ST-SRef FMT-INC/SND2Ref FMT-INC/SGRRef FMT-INC/MDP2
by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- Reusable Incubator Skin Temperature Probe EUDAMED
- Device Name
- Non-Sterile Medical Temperature Probe EUDAMED
- Model / Reference
- FMT-INC/SIS EUDAMEDFMT-INC/SND3 EUDAMEDFMT-INC/MDP EUDAMEDFMT-INC/SRS EUDAMEDFMT-INC/SND EUDAMEDFMT-INC/SFP EUDAMEDFMT-INC/SO2 EUDAMEDFMT-INC/ST-S EUDAMEDFMT-INC/SND2 EUDAMEDFMT-INC/SGR EUDAMEDFMT-INC/MDP2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698870342072 EUDAMED08698870342645 EUDAMED08698870376305 EUDAMED08698870355263 EUDAMED08698870342126 EUDAMED08698870342591 EUDAMED08698870342096 EUDAMED08698870371621 EUDAMED08698870342584 EUDAMED08698870342102 EUDAMED08698870376312 EUDAMED
- Basic UDI-DI
- B-08698870342072 EUDAMEDB-08698870342645 EUDAMEDB-08698870376305 EUDAMEDB-08698870355263 EUDAMEDB-08698870342126 EUDAMEDB-08698870342591 EUDAMEDB-08698870342096 EUDAMEDB-08698870371621 EUDAMEDB-08698870342584 EUDAMEDB-08698870342102 EUDAMEDB-08698870376312 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 Incubator Skin Temperature Probe by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ — Class IIb — FDA_510K, MDD — listed in…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213100 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08698870342072 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022486
Sources (12)
- EUDAMED 6ed72b35-1690-4ef6-ac26-7f410b01a171 61 fields · synced Sep 18, 2026
- EUDAMED 75428c8e-1127-4449-9c9a-10320212d422 61 fields · synced May 16, 2026
- EUDAMED 9a9e86e4-14dd-40d6-96c3-bf1d0e67ea28 61 fields · synced May 16, 2026
- EUDAMED 227d0f0f-1a9f-4811-93cc-579e8a11afa7 61 fields · synced May 16, 2026
- EUDAMED 76bb63fe-d357-4333-a4e0-5021e66e9d24 61 fields · synced May 17, 2026
- EUDAMED 54b202b8-fa14-4f19-ad3b-72cf452d98a1 61 fields · synced May 17, 2026
- EUDAMED a687d64a-a8f5-4b1a-a064-6922b21aefcc 61 fields · synced May 17, 2026
- EUDAMED 8c6f512e-842c-452e-8b5b-13dcbfba315e 61 fields · synced May 18, 2026
- EUDAMED 745c777d-9636-407d-a068-af9eaeecfc4c 61 fields · synced May 18, 2026
- EUDAMED e13ace39-8679-4614-994a-8959f8cb8b6e 61 fields · synced May 19, 2026
- EUDAMED 01849618-e00b-4060-adb1-67aedc248c32 61 fields · synced May 19, 2026
- FDA 510(k) K213100 1 fields · synced May 18, 2026