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Arm blood pressure monitor
EUDAMEDClass IIa (EU MDR)
Ref BP103AModel BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126ARef BP126A(TMA-INTEL 9)Ref BP105A(TECH PRO)Ref BP168A(TMA-INTEL 7)Model BP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-CRef BP126ARef BP163ARef BP820AModel BP118A ，BP810A，BP102A，BP820A，BPCB0A-2H，BP880ARef BPCB0A-3H(BP-3H)
Identity
- Trade Name
- Arm blood pressure monitor EUDAMED
- Device Name
- Blood Pressure Monitors EUDAMEDBlood Pressure Monitor EUDAMED
- Model / Reference
- BP106A，BP866A，BP105A，BP108A，BPCB0A-2A，BP126A EUDAMEDBP103A EUDAMEDBP126A(TMA-INTEL 9) EUDAMEDBP105A(TECH PRO) EUDAMEDBP100A，BP101A，BP103A，BPCB0A-3H，BP163A，BP168A，BP122A，CUFF-A，CUFF-B，CUFF-C EUDAMEDBP168A(TMA-INTEL 7) EUDAMEDBP126A EUDAMEDBP163A EUDAMEDBP118A ，BP810A，BP102A，BP820A，BPCB0A-2H，BP880A EUDAMEDBP820A EUDAMEDBPCB0A-3H(BP-3H) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158400515 EUDAMED06948158400447 EUDAMED06948158400409 EUDAMED06948158400201 EUDAMED06948158400355 EUDAMED06948158400522 EUDAMED06948158400751 EUDAMED06948158400492 EUDAMED
- Basic UDI-DI
- 69481584ARM04T8 EUDAMED69481584ARM02T4 EUDAMED69481584ARM03T6 EUDAMED
- Direct Marketing DI
- 06948158400515 EUDAMED06948158400447 EUDAMED06948158400409 EUDAMED06948158400201 EUDAMED06948158400355 EUDAMED06948158400522 EUDAMED06948158400751 EUDAMED06948158400492 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDItaly EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Arm blood pressure monitor by Shenzhen Combei Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69481584ARM04T8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (8)
- EUDAMED 32b48b32-056f-436c-a1f3-b68a6dd4a14a 61 fields · synced Oct 6, 2026
- EUDAMED e2b935fd-45a0-4e04-8990-7ff4276d2bea 61 fields · synced May 11, 2026
- EUDAMED 65137915-3677-41a6-9eaf-efbc76782c18 61 fields · synced May 16, 2026
- EUDAMED 172aec26-821b-4bab-aa8f-def23c74f89a 61 fields · synced May 17, 2026
- EUDAMED 46b9055a-63ef-4cf8-9fd4-5e37f0b6c88d 61 fields · synced May 17, 2026
- EUDAMED 2d1d5dd7-5279-4c40-996a-8332c1d653e5 61 fields · synced May 17, 2026
- EUDAMED f15b52ac-780f-4604-a263-de2301690ca6 61 fields · synced May 17, 2026
- EUDAMED e25d67fc-8465-4dd6-8fe5-52cf613d665d 61 fields · synced May 18, 2026