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Interface Cable Procedure Pack
EUDAMEDFDA UDIClass I (EU MDR)
Ref 7-RS2-210
by Creo Medical
Identity
- Trade Name
- Interface Cable Procedure Pack EUDAMEDCreo Medical FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Interface Cable Procedure Pack EUDAMEDA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. FDA UDI
- Model / Reference
- 7-RS2-210 EUDAMEDFDA UDI
- Description
- A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060359560063 EUDAMEDFDA UDI
- Basic UDI-DI
- 506035956InterfaceCaRS26D EUDAMED
- 510(k) Number
- K171983 FDA UDI
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical-only medical device connection cable, reusable
Interface Cable Procedure Pack by Creo Medical — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 506035956InterfaceCaRS26D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Creo Medical
- EUDAMED SRN
- GB-MF-000019076
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (2)
- EUDAMED 94d78fa4-47a2-4571-93f1-dc4e3d1b85f3 61 fields · synced Jun 19, 2026
- FDA UDI c2f6f453-3559-418c-8d3f-578db62daa9c 36 fields · synced May 30, 2026