Identity
- Trade Name
- Cell Therapy 360 Wearable Tech V1 FDA UDI
- Generic Name
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
- Device Name
- Cell Therapy 360 Wearable Tech V1 EUDAMEDBMS CT360 Clinician Web App FDA UDI
- Model / Reference
- N/A EUDAMEDBMS CT360 Clinician Web App FDA UDI
- Description
- BMS CT360 Clinician Web App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851203006272 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851203006272 EUDAMED
- 510(k) Number
- K143267 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cell Therapy 360 Wearable Tech V1 by Blue Spark Technologies, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00851203006272 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Blue Spark Technologies, Inc.
- EUDAMED SRN
- US-MF-000026609
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 66ccd201-8881-48c5-a9c7-6b06030e1fe5 61 fields · synced Jun 18, 2026
- FDA UDI b688245d-ffa0-4b82-b7fb-4790f455a42c 35 fields · synced May 30, 2026