Identity
- Trade Name
- FlexiPort EUDAMEDWelch Allyn, Inc. FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- CUFF WA SOFT LG ADULT LONG FDA UDI
- Model / Reference
- 901044 EUDAMEDFDA UDISOFT-12L EUDAMED
- Description
- CUFF WA SOFT LG ADULT LONG FDA UDI
Identifiers
- Catalog Number
- SOFT-12LUNO FDA UDI
- Primary DI / UDI-DI
- 00732094187823 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732094GMN901044F2 EUDAMED
- Direct Marketing DI
- 00732094187823 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
- 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 UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
FlexiPort 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 | 0732094GMN901044F2 | 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 (2)
- EUDAMED eea156ad-8bcf-4fe1-afb3-eda6a7251a0f 61 fields · synced May 30, 2026
- FDA UDI 5c555c4d-89b0-417c-9667-72a3e51d8522 35 fields · synced May 30, 2026