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Arm t ype B lood Pressure Monitor Cuff
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 6NRSI-KRef 6NRUI-KRef 6NRXI-KRef 6COMI K
Identity
- Trade Name
- Arm Type Blood Pressure Monitor Cuff EUDAMED
- Device Name
- Arm t ype B lood Pressure Monitor Cuff EUDAMED
- Model / Reference
- 6NRSI-K EUDAMED6NRUI-K EUDAMED6NRXI-K EUDAMED6COMI K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953425282 EUDAMED04710953425312 EUDAMED04710953425299 EUDAMED04710953426296 EUDAMED
- Basic UDI-DI
- 471095342TCF09CUFFX7 EUDAMED
- Direct Marketing DI
- 04710953425282 EUDAMED04710953425312 EUDAMED04710953425299 EUDAMED04710953426296 EUDAMED
- EMDN Code
- Z12039080 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arm t ype B lood Pressure Monitor Cuff by Avita Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250765 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471095342TCF09CUFFX7 | Class I | Active |
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Manufacturer
- Manufacturer
- AViTA Corporation
- EUDAMED SRN
- TW-MF-000010455
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED aa36b3b6-a749-41ec-99ad-979ec9bd45d0 61 fields · synced Oct 7, 2026
- EUDAMED 464a989f-d9e8-4573-b633-a06feb61c67e 61 fields · synced May 18, 2026
- EUDAMED ae0ded6d-bfde-43c9-8d5d-b5a9288644c4 61 fields · synced May 18, 2026
- EUDAMED 13cfe1ce-eb86-4a38-936f-e861a49967a3 61 fields · synced Jul 21, 2026
- FDA 510(k) K250765 1 fields · synced May 18, 2026