Identity
- Trade Name
- CathGrip EUDAMEDFDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- CathGrip Securement Device Non-Sterile EUDAMEDCathGrip Oval, Large, Non-Sterile, No Alcohol FDA UDI
- Model / Reference
- 54003NSNA EUDAMEDFDA UDI
- Description
- CathGrip Oval, Large, Non-Sterile, No Alcohol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00653599001424 EUDAMEDFDA UDI
- Basic UDI-DI
- 0653599CGNS3R 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
- Malta 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
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 | 0653599CGNS3R | 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 001e90d5-37f4-40c1-ae81-dadf7bb78657 61 fields · synced Oct 6, 2026
- FDA UDI 21ef2d85-412f-4cba-937c-fae7b4074b25 35 fields · synced May 30, 2026