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Blood Pressure Cuff
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0814Model 0814, 1320, 1826, 2635, 2938, 3242, 3544, 4250, N1, N2, N3, N4, N5, SV1, SV2, SV3,SV4, SV5, SV8
Identity
- Trade Name
- Claricuff™ FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Blood Pressure Cuff EUDAMED
- Model / Reference
- 0814, 1320, 1826, 2635, 2938, 3242, 3544, 4250, N1, N2, N3, N4, N5, SV1, SV2, SV3,SV4, SV5, SV8 EUDAMED0814 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971919469025 EUDAMEDFDA UDI
- Basic UDI-DI
- 697191946BPCTY EUDAMED
- 510(k) Number
- K173044 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Belgium 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blood Pressure Cuff by Ningbo Albert Novosino Co., Ltd. — Class I — 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 | 697191946BPCTY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 6400a1d6-d6bd-4e8a-b4b8-eff6ea377e19 61 fields · synced Jun 8, 2026
- FDA UDI 9a47410a-fa6c-48fc-b4ce-6182c907a521 33 fields · synced May 30, 2026