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BP-200 Plus
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 3.930300Model BP-200 Plus
by Schiller Ag
Identity
- Trade Name
- BP-200 Plus EUDAMEDSCHILLER FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- BP-200 Plus EUDAMEDThe BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturationin arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races. FDA UDI
- Model / Reference
- BP-200 Plus EUDAMEDFDA UDI3.930300 EUDAMED
- Description
- The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturationin arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races. FDA UDI
Identifiers
- Catalog Number
- 3.930300 FDA UDI
- Primary DI / UDI-DI
- 07613365000122 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07613365000122 EUDAMED
- 510(k) Number
- K063814 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- France 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
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
BP-200 Plus by Schiller AG — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, 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 | K063814 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07613365000122 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schiller Ag
- EUDAMED SRN
- CH-MF-000012722
- Authorised Representative
- SCHILLER Medizintechnik GmbH DE-AR-000006934
Sources (3)
- EUDAMED 195ca903-005e-4048-bf8c-3bc39c921a44 61 fields · synced Jun 19, 2026
- FDA UDI 6192698d-d8d6-4a91-9947-f500fa967f2d 37 fields · synced May 30, 2026
- FDA 510(k) K063814 1 fields · synced May 18, 2026