SURE-LOCK Electrode Clip
by Curbell Medical Products, Inc United States EUDAMEDGUDID
Ref 26867Model CL-10401-05-14
Product code DSAEMDN C020599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084082818337A3 | Date10 Jan 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00840828183376 | Date27 Apr 2021 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- SURE-LOCK Electrode Clip EUDAMEDSure LOCK,A34,14 Pk,green Lever,vyaire GUDID
- Generic Name
- Electrocardiographic electrode, reusable
- Model / Ref / Catalog
- CL-10401-05-14, 26867
- Primary DI / UDI-DI
- 00840828183376
- Basic UDI-DI
- 084082818337A3
- Direct Marketing DI
- 00840828183376
- 510(k) Number
- FDA Product Code
- DSA
- EMDN Code
- C020599 Cardiac diagnostic devices - other
- GMDN Term
- Electrocardiographic electrode, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2900
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000002618
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Curbell Medical Products, Inc
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 52b11f86-a947-465a-8c3f-2d5d9c713a14
- FDA UDI 886a2d8d-66fc-4422-9ab8-07126ae08372