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Wrist-Type Fully Automatic Blood Pressure Monitor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DBP-8197Ref DBP-2116Ref DBP-2141Ref DBP-2208Ref SBC 35Ref DBP-2272Ref DBP-2101Ref DBP-2242
Identity
- Trade Name
- Wrist-Type Fully Automatic Blood Pressure Monitor EUDAMEDMEDLOT Wrist-Type Fully Automatic Blood Pressure Monitor EUDAMEDMEDLOT FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Wrist-type Fully Automatic Electronic Blood Pressure Monitor EUDAMEDWrist-Type Fully Automatic Blood Pressure Monitor EUDAMEDBlood Pressure Monitor EUDAMED
- Model / Reference
- DBP-8197 EUDAMEDDBP-2116 EUDAMEDDBP-2141 EUDAMEDDBP-2208 EUDAMEDFDA UDISBC 35 EUDAMEDDBP-2272 EUDAMEDDBP-2101 EUDAMEDDBP-2242 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392214320 EUDAMED06970392216454 EUDAMED06970392216461 EUDAMED06942284615492 EUDAMED06942284615386 EUDAMEDFDA UDI06942284615638 EUDAMED06942284615294 EUDAMED03401547947587 EUDAMED06942284616611 EUDAMED
- Basic UDI-DI
- 6970392211BP0006YF EUDAMEDB-06970392216454 EUDAMED6970392211BP0003Y9 EUDAMED
- Direct Marketing DI
- 06970392214320 EUDAMED06942284615492 EUDAMED06942284615386 EUDAMED06970392216454 EUDAMED06942284615638 EUDAMED06942284615300 EUDAMED03401547947587 EUDAMED06942284616611 EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES 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
- France EUDAMEDBulgaria EUDAMEDMalta EUDAMEDItaly EUDAMEDGermany EUDAMEDSpain 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
Yes
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
Yes
FDA UDI
Wrist-Type Fully Automatic Blood Pressure Monitor by Joytech Healthcare Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6970392211BP0006YF | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211BP0006YF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (11)
- EUDAMED 93d8cb00-7cea-4830-8896-dda8bedd6d47 61 fields · synced Sep 18, 2026
- EUDAMED d994a8e5-4664-4e9b-be98-5852d1e028be 61 fields · synced May 16, 2026
- EUDAMED 2707a414-356c-4136-ad4f-7c79dd661e5a 61 fields · synced May 16, 2026
- EUDAMED c96c327e-300c-4680-869d-87da84fd9f2d 61 fields · synced May 17, 2026
- EUDAMED c7254672-6913-41b3-ae14-1221dd29f152 61 fields · synced May 18, 2026
- FDA UDI 66d32664-e16b-4084-a751-5172a244233a 32 fields · synced May 30, 2026
- EUDAMED 9735df1b-17bb-4846-85c0-2926975c222c 61 fields · synced Jul 10, 2026
- EUDAMED 4ef4ad53-1087-4a4a-9451-75c0e6802a60 61 fields · synced Jul 26, 2026
- EUDAMED a341ac4c-f9f4-4772-b0ff-ce68efb3830f 61 fields · synced Jul 27, 2026
- EUDAMED d37682f9-64a3-4cce-8fe7-0732dc6eec2b 61 fields · synced Aug 4, 2026
- EUDAMED 574875c1-9901-437a-8bec-c6ef8f18e4a9 61 fields · synced Sep 18, 2026