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Edi Catheter ENFit 6Fr/50cm
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 6883899510(k) K153688
Identity
- Trade Name
- Edi Catheter ENFit 6Fr/50cm EUDAMEDEdi Catheter ENFIT 6Fr/50 cm EUDAMEDEdi Catheter ENFit 6Fr/50 cm, 5pcs FDA UDI
- Generic Name
- Nasogastric feeding tube FDA UDI
- Device Name
- Edi Catheter ENFit EUDAMED
- Model / Reference
- 6883899 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17325710015336 EUDAMED07325710015339 EUDAMED07325710004616 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 UDIEUDAMED
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 6Fr/50cm by Maquet Critical Care AB — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153688 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 73257100046793 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
- EUDAMED SRN
- SE-MF-000001264
Sources (4)
- EUDAMED 4f22847d-319b-43ce-98b0-ade31c0927e6 85 fields · synced Oct 7, 2026
- FDA UDI e8583461-35d1-496e-b215-7ab20a191099 33 fields · synced May 30, 2026
- EUDAMED 95219bc4-b4a9-4624-95a3-828c0c4e095d 61 fields · synced Jul 17, 2026
- FDA 510(k) K153688 1 fields · synced May 18, 2026