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Edi Catheter ENFit 12Fr/125 cm, 5pcs
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 6883903
Identity
- Trade Name
- Edi Catheter ENFit 12Fr/125 cm EUDAMEDEdi Catheter ENFit 12Fr/125 cm, 5pcs FDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Edi Catheter ENFit EUDAMED
- Model / Reference
- 6883903 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710015377 EUDAMED07325710004661 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
- Sweden 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
Category: Nasogastric feeding tube
Edi Catheter ENFit 12Fr/125 cm, 5pcs by Maquet Critical Care AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasogastric feeding tube.
- MED-RX — Canadian Hospital Specialties Limited · Class II
- ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector — ENVIZION MEDICAL LTD · Class II
- NeoDevices, Inc. — NEODEVICES INC · Class II
- CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
- VYGON — Vygon Corp. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
- Enteral — GBUK ENTERAL LIMITED · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (2)
- FDA UDI 8f0a76d4-aa4a-4c7b-98ca-b546c2764405 33 fields · synced Sep 18, 2026
- EUDAMED dc3d33f1-60b6-4f45-a5e3-fb32af826f83 61 fields · synced Sep 18, 2026