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TrueLife Pulse
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AS-35AModel AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110
Identity
- Trade Name
- TrueLife Pulse EUDAMEDMarathon FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Automated non-invasive Sphygmomanometer EUDAMEDAutomatic digital blood pressure monitor FDA UDI
- Model / Reference
- AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110 EUDAMEDAS-35A EUDAMEDFDA UDI
- Description
- Automatic digital blood pressure monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08594175354324 EUDAMED06947707702322 FDA UDI
- Basic UDI-DI
- 6947707706016CS EUDAMED
- 510(k) Number
- K190982 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
TrueLife Pulse by Xiamen Ants-Bro Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6947707706016CS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Ants-Bro Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010562
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 62093aff-371b-48f2-bf04-45c4a41a97bd 61 fields · synced Jun 19, 2026
- FDA UDI 4f38f6e4-8309-4227-9352-cd6bb048ba2d 34 fields · synced May 30, 2026