Identity
- Trade Name
- NIBP Cuff EUDAMED
- Device Name
- Accessories for Sphygmomanometer and Sphygmograph EUDAMED
- Model / Reference
- CUF-250S-LA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612915505 EUDAMED
- Basic UDI-DI
- 4538612011019M EUDAMED
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
NIBP Cuff by Fukuda Denshi Co., Ltd. — Class I — 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 | 4538612011019M | Class I | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6a5a3540-4e94-4e0b-bc1f-9ca7fdde73dc 61 fields · synced Jun 18, 2026