Direct ECG Legplate Adapter Cable
by Unimed Medical Supplies, Inc EUDAMEDGUDID
Active
Ref AD-UFT-003
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69456648REC1YF | Date23 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number06945664899512 | Date14 Jul 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Direct ECG Legplate Adapter Cable EUDAMEDUnimed GUDID
- Generic Name
- Electrical-only medical device connection cable, reusable
- Device Name
- ECG Cables & Lead Wires
- Model / Reference
- AD-UFT-003
- Primary DI / UDI-DI
- 06945664899512
- Basic UDI-DI
- 69456648REC1YF
- FDA Product Code
- DSA
- EMDN Code
- Z12050385 Electrocardiographs - consumables
- GMDN Term
- Electrical-only medical device connection cable, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2900
- Market of Registration
- Sweden
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000001480
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Unimed Medical Supplies, Inc.
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No