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Registry EUDAMED ~400 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~400

More countries (1)

Italy ~400

Risk class Class I ~400 Class IIa Class IIb Class III Class II (US)

More classes (11)

Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Manufacturer: B&T Spa× Clear all

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TempTraq UDI-DI 00851203006302

Blue Spark Technologies, Inc.,United States Class IIa

Active CE MDD EUDAMEDGUDID IIa
29 variants
- TempTraq 607
- TempTraq 632
- TempTraq 639
- TempTraq 640
- TempTraq 647
- TempTraq UDI-DI 00851203006043
- TempTraq UDI-DI 00851203006135
- TempTraq UDI-DI 00851203006364
- TempTraq UDI-DI 00851203006388
- TempTraq K143267
- TempTraq K201977
- See all variants of this device
Cell Therapy 360 Wearable Tech V1 UDI-DI 00851203006258

Blue Spark Technologies, Inc.,United States Class IIa

Active CE MDD EUDAMEDGUDID IIa
6 variants
- Cell Therapy 360 Wearable Tech V1 622
- Cell Therapy 360 Wearable Tech V1 UDI-DI 00851203006234
- Cell Therapy 360 Wearable Tech V1 UDI-DI 00851203006272
- See all variants of this device
MFLI0520-M000033769

B&T Spa,Italy Class I

Active CE MDR EUDAMED I
MCCN0217-M000004993

B&T Spa,Italy Class I

Active CE MDR EUDAMED I
MFLI0520-M000016989

B&T Spa,Italy Class I

Active CE MDR EUDAMED I
MNUV20M0725-M000047910

B&T Spa,Italy Class I

Active CE MDR EUDAMED I

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