Identity
- Trade Name
- Edi Catheter ENFit 8Fr/100cm EUDAMEDEdi Catheter ENFIT 8Fr/100 cm EUDAMEDEdi Catheter ENFit 8Fr/100 cm, 5pcs FDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Edi Catheter ENFit EUDAMED
- Model / Reference
- 6883901 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17325710015350 EUDAMED07325710015353 EUDAMED07325710004647 FDA UDI
- Basic UDI-DI
- 73257100046793 EUDAMED
- 510(k) Number
- K153688 FDA UDI
- FDA Product Code
- PIF FDA UDICBK FDA UDI
- EMDN Code
- G02020101 NASOGASTRIC TUBES EUDAMED
- GMDN Term
- Nasogastric feeding tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI868.5895 FDA UDI
- Market of Registration
- Germany EUDAMEDSweden 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
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Edi Catheter ENFit 8Fr/100cm by Maquet Critical Care AB — Class IIa — 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 | 73257100046793 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (3)
- EUDAMED 7a9c726a-1f5f-4e63-9d0e-6360948ebfbe 61 fields · synced Oct 7, 2026
- FDA UDI 441c7ad7-8dc8-4f6d-8dad-00a6af07853e 33 fields · synced May 30, 2026
- EUDAMED a2aa5ca3-cb17-4172-a21a-3e75c52b47a5 61 fields · synced Jul 9, 2026