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FlexiPort EcoCuff
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref ECOCUFF-09Model 901045
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-09 Child, Single-Patient Use, No Tubes or Connectors; Qty. 100 FDA UDIECO CUFF CHILD BOX OF 50 FDA UDI
- Model / Reference
- 901045 EUDAMEDFDA UDIECOCUFF-09 EUDAMED
- Description
- Welch Allyn FlexiPort ECO Blood Pressure Cuff; Size-09 Child, Single-Patient Use, No Tubes or Connectors; Qty. 100 FDA UDIECO CUFF CHILD BOX OF 50 FDA UDI
Identifiers
- Catalog Number
- ECOCUFF-09 FDA UDIECOCUFF-09ILB FDA UDI
- Primary DI / UDI-DI
- 00732094237016 EUDAMEDFDA UDI00732094177350 FDA UDI
- Basic UDI-DI
- 0732094GMN901045F4 EUDAMED
- Unit of Use DI
- 00732094203943 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K122058 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0732094GMN901045F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
- EUDAMED SRN
- US-MF-000013394
- Authorised Representative
- Welch Allyn Limited IE-AR-000000768
Sources (4)
- EUDAMED a3c6f983-3f1d-4fb9-a259-deb0d961ae7b 61 fields · synced Oct 6, 2026
- FDA UDI fe0a41bf-e80f-4e52-b3b9-87eee7ea1719 36 fields · synced May 27, 2026
- FDA UDI 5e7b1133-26ff-483a-bcc4-f790fecc9180 35 fields · synced May 30, 2026
- FDA 510(k) K122058 1 fields · synced May 18, 2026