BPro BT ABPM System
by Healthstats International Pte Ltd
Ref T6222Model T6200 Series
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0888501441T6222WF 08885014410098 | Date19 Aug 2022 | StatusWithdrawn |
| United States | GUDID listing GUDID | Number08885014410098 | Date14 Aug 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- BPro BT ABPM System EUDAMEDBPro BT Ambulatory Blood Pressure Monitoring System GUDID
- Generic Name
- Blood pressure ambulatory recorder
- Model / Reference
- T6200 Series, T6222
- Primary DI / UDI-DI
- 08885014410098
- Basic UDI-DI
- 0888501441T6222WF
- 510(k) Number
- FDA Product Code
- DXN
- EMDN Code
- Z1203020302 Non–invasive blood pressure monitoring instruments
- GMDN Term
- Blood pressure ambulatory recorder
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.1130
- EU market of registration
- Ireland
- GUDID distribution status
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- SG-MF-000025200
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Healthstats International Pte Ltd
Properties
Other properties (22)
- 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
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No