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NIBP Cuff
EUDAMEDClass I (EU MDR)
Ref F1BR201Model F1BR201, F1BR202, F1BR203, F1BD301
Identity
- Device Name
- NIBP Cuff EUDAMED
- Model / Reference
- F1BR201, F1BR202, F1BR203, F1BD301 EUDAMEDF1BR201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977704920085 EUDAMED
- Basic UDI-DI
- 697770492F1NIBPCTU EUDAMED
- EMDN Code
- Z12030685 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Shenzhen F1 Technology 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 | 697770492F1NIBPCTU | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen F1 Technology CO., Ltd
- EUDAMED SRN
- CN-MF-000043372
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d360868e-11f3-4a21-93a1-62f964579361 61 fields · synced Jun 19, 2026