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TempTraq
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 642Model TT-300Ref 647Model TT-100Ref 639Ref 641Ref 635Ref 646Ref 645Ref 648
Identity
- Device Name
- TempTraq EUDAMED
- Model / Reference
- TT-300 EUDAMED642 EUDAMEDTT-100 EUDAMED647 EUDAMED639 EUDAMED641 EUDAMED635 EUDAMED646 EUDAMED645 EUDAMED648 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851203006425 EUDAMED00851203006470 EUDAMED00851203006395 EUDAMED00851203006418 EUDAMED00851203006357 EUDAMED00851203006463 EUDAMED00851203006456 EUDAMED00851203006487 EUDAMED
- Basic UDI-DI
- B-00851203006425 EUDAMEDB-00851203006470 EUDAMEDB-00851203006395 EUDAMEDB-00851203006418 EUDAMEDB-00851203006357 EUDAMEDB-00851203006463 EUDAMEDB-00851203006456 EUDAMEDB-00851203006487 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TempTraq by Blue Spark Technologies, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K143267 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00851203006425 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Spark Technologies, Inc.
- EUDAMED SRN
- US-MF-000026609
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (9)
- EUDAMED 3a18c46f-fcce-4874-ada2-cc41f800cc0a 61 fields · synced Jul 27, 2026
- EUDAMED cd2d3f4d-e41d-4de5-89df-23459458b010 61 fields · synced May 17, 2026
- EUDAMED ac0bc166-6d92-4fc3-9938-a0804f593e00 61 fields · synced May 17, 2026
- EUDAMED 17bd4739-f288-48d4-83d6-72d4e6c9f928 61 fields · synced May 17, 2026
- EUDAMED 80d94b01-aa7b-4145-a7ef-e9aa7dfec8c6 61 fields · synced May 18, 2026
- EUDAMED 7f3b061e-fd20-4357-87ff-cd203eb5274a 61 fields · synced May 18, 2026
- EUDAMED 79fee930-80df-489c-8afa-52f4d114b314 61 fields · synced May 18, 2026
- EUDAMED 81240a6d-3e12-4b68-8496-acffc5b93144 61 fields · synced May 19, 2026
- FDA 510(k) K143267 1 fields · synced May 18, 2026