Identity
- Trade Name
- Ear Suction Controller EUDAMEDAdept Medical Suction Controller FDA UDI
- Generic Name
- Ear canal suction handle FDA UDI
- Device Name
- Ear Suction Controller EUDAMED
- Model / Reference
- NZ3238S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421902825101 EUDAMEDFDA UDI
- Basic UDI-DI
- 9421905187SuctContW9 EUDAMED
- FDA Product Code
- JZF FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Ear canal suction handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Netherlands 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
Ear Suction Controller by Adept Medical Ltd — 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 | 9421905187SuctContW9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 e4a85072-dff1-4184-90da-4702bf45685f 61 fields · synced May 30, 2026
- FDA UDI 08be839d-ca51-4491-9abe-f2ed96696e16 32 fields · synced May 30, 2026