ANNE Chest Sensor Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ANNE Chest Sensor EUDAMEDANNE Chest Sensor Kit FDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitor FDA UDI
- Device Name
- ANNE One System EUDAMEDThe ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. FDA UDI
- Model / Reference
- 900-00007 EUDAMEDFDA UDISA-004-01 EUDAMED
- Description
- The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850064210002 EUDAMEDFDA UDI
- Basic UDI-DI
- 08500642100JG EUDAMED
- Direct Marketing DI
- 00850064210002 EUDAMED
- 510(k) Number
- K240251 FDA UDI
- FDA Product Code
- DRG FDA UDIBZQ FDA UDIFLL FDA UDIKMI FDA UDIMWJ FDA UDIMWI FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Wearable multiple vital physiological parameter monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI868.2375 FDA UDI880.2910 FDA UDI880.2400 FDA UDI870.2800 FDA UDI870.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Wearable multiple vital physiological parameter monitor
ANNE Chest Sensor Kit by Sibel Health Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple vital physiological parameter monitor.
- UbiqVue — LifeSignals, Inc. · Class II
- 7-Day ANNE Chest Adhesive Shelf Box — Sibel Health Inc. · Class II
- Central Hub Speaker — Sibel Health Inc. · Class II
- Sibel Spacelabs Trek Charger — Sibel Health Inc. · Class II
- ANNE View Patient Monitor — Sibel Health Inc. · Class II
- 7-Day ANNE Chest Adhesive Pouch — Sibel Health Inc. · Class II
- ANNE Bedside Wireless Charger — Sibel Health Inc. · Class II
- Central Hub CMS — Sibel Health Inc. · Class II
Cleared under the same submission
K240251 also covers:
- 1-Day ANNE Chest Adhesive Pouch — Sibel Health Inc.
- 7-Day ANNE Chest Adhesive Pouch — Sibel Health Inc.
- 7-Day ANNE Chest Adhesive Shelf Box — Sibel Health Inc.
- ANNE Bedside Wireless Charger — Sibel Health Inc.
- ANNE Chest — Sibel Health Inc.
- ANNE Chest Sensor — Sibel Health Inc.
- Sibel Spacelabs Trek Charger — Sibel Health Inc.
- Sibel Spacelabs Trek Chest Patch — Sibel Health Inc.
- Sibel Spacelabs Trek Chest Patch Adhesive — Sibel Health Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sibel Health Inc.
Sources (2)
- FDA UDI 9c54778b-d805-4d50-986d-18be78a9aec3 34 fields · synced Jun 19, 2026
- EUDAMED 783c4177-57cc-4dc2-8356-17ec5accd75d 61 fields · synced Jun 19, 2026