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Aj11
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 697160831DentalUnitYDModel AJ10, AJ11, AJ12, AJ15, AJ16, AJ17, AJ18, AJ19, AJ22, AJ25, AJ26, AJ28
Identity
- Trade Name
- AJ11 EUDAMEDADS FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- AJ10, AJ11, AJ12, AJ15, AJ16, AJ17, AJ18, AJ19, AJ22, AJ25, AJ26, AJ28 EUDAMED697160831DentalUnitYD EUDAMEDAJ11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971608310010 EUDAMEDFDA UDI
- Basic UDI-DI
- 697160831DentalUnitYD EUDAMED
- 510(k) Number
- K132245 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aj11 by Guangzhou Ajax Medical Equipment Co., 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 | 697160831DentalUnitYD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Ajax Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000016044
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 47ea7ad2-dbc8-492d-8c5c-b7091b543791 61 fields · synced Oct 6, 2026
- FDA UDI 4493fe46-a710-4c74-88f4-0d7dba8617c2 33 fields · synced May 30, 2026