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Suction Tube Bent and Controller - 18 Gauge
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref NZ3251BentModel NZ3254Bent
Identity
- Trade Name
- Suction Tube Bent and Controller - 18 Gauge EUDAMEDSuction Tube Bent and Controller - 18 Gauge -Sterile FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
- Device Name
- Suction Tube Kit - Suction Tube Bent and Controller - 14 Gauge EUDAMED
- Model / Reference
- NZ3254Bent EUDAMEDNZ3251Bent EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421901970642 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421905187SuctTubeYU EUDAMED
- FDA Product Code
- JZF FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Spain 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
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
No
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
Yes
FDA UDI
Suction Tube Bent and Controller - 18 Gauge by Adept Medical Ltd — 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 | 9421905187SuctTubeYU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 0e352b09-3aa2-417e-b442-d4e971b19267 61 fields · synced Jun 18, 2026
- FDA UDI b44eccc3-3dff-4887-88a8-6136fab3df0e 32 fields · synced May 30, 2026