Identity
- Trade Name
- Oximeter Probe Adapter Cable EUDAMEDMed-link FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient Cable and leadwires EUDAMED
- Model / Reference
- S0015OX-L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944414009874 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444140001SE EUDAMED
- 510(k) Number
- K120010 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
Med-link by Shenzhen Med-Link Electronics Tech Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K120010 also covers:
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
- Sensoronics — SENSORONICS INCORPORATED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Sources (2)
- FDA UDI a7e28e2e-f7c2-4400-aaa0-7e90ee3d2036 33 fields · synced Jul 8, 2026
- EUDAMED 6d0a32b3-bac5-4fb4-b888-16233da51f41 61 fields · synced Jul 8, 2026