← Back to catalogue
Guide wire for Edi Catheter 8 Fr 125 cm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6671292
Identity
- Trade Name
- Guide wire for Edi Catheter 8 Fr 125 cm EUDAMEDGuide Wire for Edi catheter 8Fr/125 cm FDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Guide wire for Edi Catheter EUDAMED
- Model / Reference
- 6671292 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710006528 EUDAMEDFDA UDI
- Basic UDI-DI
- 7325710006528Y EUDAMED
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G0280 GASTROINTESTINAL TUBES - ACCESSORIES EUDAMED
- GMDN Term
- Nasogastric feeding tube FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Guide wire for Edi Catheter 8 Fr 125 cm by Maquet Critical Care AB — 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 | 7325710006528Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (2)
- EUDAMED 9d28dbb7-9d38-4bb6-8798-319480ddc159 61 fields · synced Oct 6, 2026
- FDA UDI c5a1c765-37a4-419d-89f1-7a7798cfcb81 32 fields · synced May 30, 2026