Identity
- Trade Name
- DOPPLEX EUDAMEDFDA UDI
- Generic Name
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
- Device Name
- ABILITY STANDARD CUFF SET EUDAMEDADULT LEFT ANKLE CUFF FDA UDI
- Model / Reference
- ACC-VAS-006 EUDAMEDACC-VAS-026 EUDAMEDFDA UDI
- Description
- ADULT LEFT ANKLE CUFF FDA UDI
Identifiers
- Catalog Number
- ACC-VAS-026 FDA UDI
- Primary DI / UDI-DI
- 05051968030504 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520433WA EUDAMED
- 510(k) Number
- K121108 FDA UDI
- FDA Product Code
- JOM FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2780 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dopplex by Arjohuntleigh AB — 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 | 5060693520433WA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED 88ffadbb-051c-4532-a570-7336e8e63c80 61 fields · synced Aug 4, 2026
- FDA UDI 24abe1f5-209e-4322-a2f8-23bd6f3efe15 37 fields · synced May 30, 2026