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NIBP Cuff
EUDAMEDFDA UDIClass I (EU MDR)
Ref Infant E5Ref Small Adult E8Ref Adult E9Ref A8Ref RPAYACC036Ref A7Ref Thigh E11Ref A10Ref A11Ref A6Ref Large Adult E10Ref Small child E6
Identity
- Trade Name
- NIBP Cuff EUDAMEDFDA UDIRespArray NIBP Cuff FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP Cuff EUDAMED
- Model / Reference
- Infant E5 EUDAMEDSmall Adult E8 EUDAMEDAdult E9 EUDAMEDA8 EUDAMEDRPAYACC036 EUDAMEDA7 EUDAMEDThigh E11 EUDAMEDA10 EUDAMEDA11 EUDAMEDA6 EUDAMEDLarge Adult E10 EUDAMEDSmall child E6 EUDAMED01.57.472317 FDA UDI01.57.471907 FDA UDIThigh, 42cm-54cm, reusable FDA UDIInfant,10cm-15cm, reusable FDA UDILarger Adult, 34cm-43cm, reusable FDA UDIAdult,27cm-35cm, reusable FDA UDISmall adult,20.5cm-28cm, reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413804487 EUDAMEDFDA UDI06944413824805 EUDAMEDFDA UDI06944413811874 EUDAMEDFDA UDI06944413804548 EUDAMEDFDA UDI06944413804609 EUDAMEDFDA UDI06944413804593 EUDAMEDFDA UDI06944413804524 EUDAMEDFDA UDI06944413804517 EUDAMEDFDA UDI06944413804531 EUDAMEDFDA UDI06944413817166 EUDAMED06944413817159 EUDAMED06944413817197 EUDAMED06944413817203 EUDAMED06944413817142 EUDAMED06944413841055 EUDAMED
- Basic UDI-DI
- 69444138NIBPCuffJ4 EUDAMED69444138NIBPCuff349 EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES 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
- Germany 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
Yes
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 UDIFDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrical-only medical device connection cable, reusable
NIBP Cuff by Edan Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 69444138NIBPCuffJ4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (24)
- EUDAMED e1d74ed5-4d4f-49e3-b108-5011aba22137 61 fields · synced Sep 18, 2026
- FDA UDI b22e9f08-b727-4d22-bf34-0aa0dbbb8f3a 33 fields · synced May 25, 2026
- FDA UDI 7c26223e-ff45-455e-b67f-7dda60b7ff94 33 fields · synced May 29, 2026
- FDA UDI f7083e2f-d1b7-46d0-bb92-fdc8f22451f2 32 fields · synced May 29, 2026
- FDA UDI 4217f444-ba59-47aa-99c9-4bf54f356181 32 fields · synced May 29, 2026
- FDA UDI dfdc84ff-91e1-45be-8189-239bd50601ff 32 fields · synced May 29, 2026
- FDA UDI 75db56cd-8007-45ce-a784-26452eece612 32 fields · synced May 29, 2026
- FDA UDI 4df627ec-4139-4395-982b-4d796afd00c4 32 fields · synced May 30, 2026
- FDA UDI f638a004-f4ac-4db7-9abd-1c30bd481fa3 32 fields · synced May 30, 2026
- FDA UDI b0d9652e-977f-4d36-a768-ce2171becb04 32 fields · synced May 30, 2026
- EUDAMED 20290a61-dea2-4515-9bdf-b9965494cb3f 61 fields · synced Jul 10, 2026
- EUDAMED f8f22105-0d48-4fe2-a493-366170d31e50 61 fields · synced Jul 10, 2026
- EUDAMED 2137f6d5-d28a-46c6-bf44-a26b720a60c0 61 fields · synced Jul 10, 2026
- EUDAMED a2896a5e-2b4e-452b-96bf-e89f7c69ab8b 61 fields · synced Jul 10, 2026
- EUDAMED 01f0eed3-5bfc-4f77-a65c-154c974c9990 61 fields · synced Jul 10, 2026
- EUDAMED 8105e9a7-c295-4951-9b01-7e2133a1ee35 61 fields · synced Jul 11, 2026
- EUDAMED d35347cd-6294-404c-a08a-1f3fc6963eee 61 fields · synced Jul 11, 2026
- EUDAMED 3113fc2d-f0c5-4fa6-a945-64078d969f7c 61 fields · synced Jul 14, 2026
- EUDAMED 86cec2d2-b0ca-4987-912f-7a9f88cb4c4e 61 fields · synced Jul 17, 2026
- EUDAMED 8fc449a0-6a9e-482f-8ea7-8fd1f3caed46 61 fields · synced Jul 25, 2026
- EUDAMED 90818f6a-c68d-4ab7-b131-c036b6bbedeb 61 fields · synced Aug 1, 2026
- EUDAMED a82b803e-d8cd-41ba-9c0e-29b71275fb63 61 fields · synced Aug 2, 2026
- EUDAMED 93125a0e-fad1-41a7-930f-75638b960bf0 61 fields · synced Aug 3, 2026
- EUDAMED edde2cdf-fcda-4e3b-bd58-1a5e4ade1143 61 fields · synced Sep 18, 2026