Identity
- Trade Name
- DOPPLEX EUDAMEDFDA UDI
- Generic Name
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
- Device Name
- VASC WAVEFORM DOPPLER EUDAMEDABILITY-USA + PRINTER FDA UDI
- Model / Reference
- DMX EUDAMEDDA100P EUDAMEDFDA UDI
- Description
- ABILITY-USA + PRINTER FDA UDI
Identifiers
- Catalog Number
- DA100P-USA FDA UDI
- Primary DI / UDI-DI
- 05051968035370 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520365WJ EUDAMED
- 510(k) Number
- K121108 FDA UDI
- FDA Product Code
- JOM FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
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 IIa — 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 | 5060693520365WJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED 338d6348-32d1-4151-855a-4fdf10d4544b 61 fields · synced Jul 22, 2026
- FDA UDI bb5ae375-9ac8-4f02-b49e-487e7d2d752c 37 fields · synced May 30, 2026