Identity
- Trade Name
- CathGrip EUDAMEDFDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- CathGrip Securement Device Sterile EUDAMEDCathGrip Single Strap, Extra Small, Sterile, No Wipes FDA UDI
- Model / Reference
- 51023NW EUDAMEDFDA UDI
- Description
- CathGrip Single Strap, Extra Small, Sterile, No Wipes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00653599001844 EUDAMEDFDA UDI
- Basic UDI-DI
- 0653599CGSDL EUDAMED
- FDA Product Code
- KMK FDA UDI
- EMDN Code
- R020202 MOBILE CATHETER MOUNTS EUDAMED
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CathGrip by Argentum Medical, Llc — Class I — 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 | 0653599CGSDL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argentum Medical LLC
- EUDAMED SRN
- US-MF-000003391
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c7d101cd-5baa-4321-8b68-6eaf0cabcc2d 61 fields · synced Oct 5, 2026
- FDA UDI bdb866fc-b147-44f3-afac-2147ddc33225 35 fields · synced May 30, 2026