Identity
- Trade Name
- FlexiPort EcoCuff EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Welch Allyn FlexiPort ECO Blood Pressure Cuff; Size-10 Small Adult, Single-Patient Use, No Tubes or Connectors; Qty. 100 FDA UDIECO CUFF SMALL ADULT BOX OF 50 FDA UDI
- Model / Reference
- 901045 EUDAMEDFDA UDIECOCUFF-10 EUDAMED
- Description
- Welch Allyn FlexiPort ECO Blood Pressure Cuff; Size-10 Small Adult, Single-Patient Use, No Tubes or Connectors; Qty. 100 FDA UDIECO CUFF SMALL ADULT BOX OF 50 FDA UDI
Identifiers
- Catalog Number
- ECOCUFF-10 FDA UDIECOCUFF-10ILB FDA UDI
- Primary DI / UDI-DI
- 00732094236996 EUDAMEDFDA UDI00732094177367 FDA UDI
- Basic UDI-DI
- 0732094GMN901045F4 EUDAMED
- Unit of Use DI
- 00732094203950 EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z12040180 GENERAL MEDICINE DIAGNOSIS AND 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
- Ireland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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 UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
FlexiPort EcoCuff by Welch Allyn, Inc. — 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 | 0732094GMN901045F4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (3)
- EUDAMED 9d3e7df1-abd3-4e5f-9353-a4a4ff62cef6 61 fields · synced Oct 6, 2026
- FDA UDI d66f5548-c66b-4677-812e-b5d6d7afcb25 36 fields · synced May 30, 2026
- FDA UDI 8406faf9-ae1b-4bdd-844f-cac4e138d5b3 35 fields · synced May 30, 2026