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inSafe Needle Adaptor, Imperial (Yellow) - Astek
EUDAMEDFDA UDIClass I (EU MDR)
Ref 23046ASTEK
Identity
- Trade Name
- inSafe Needle Adaptor, Imperial (Yellow) - Astek EUDAMEDAstek FDA UDI
- Generic Name
- Dental anaesthesia injection kit FDA UDI
- Device Name
- inSafe Needle Adaptor EUDAMEDinSafe Needle Adaptors Imperial (Yellow) FDA UDI
- Model / Reference
- 23046ASTEK EUDAMEDFDA UDI
- Description
- inSafe Needle Adaptors Imperial (Yellow) FDA UDI
Identifiers
- Catalog Number
- 23046ASTEK FDA UDI
- Primary DI / UDI-DI
- 00843471151457 EUDAMEDFDA UDI
- Basic UDI-DI
- 0843471123044ASTEK46E4 EUDAMED
- FDA Product Code
- EJI FDA UDI
- EMDN Code
- A0299 SYRINGES - OTHER EUDAMED
- GMDN Term
- Dental anaesthesia injection kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6770 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
inSafe Needle Adaptor, Imperial (Yellow) - Astek by Young Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0843471123044ASTEK46E4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations Inc
- EUDAMED SRN
- US-MF-000017796
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED a1251e55-2de2-47be-b336-839ce8b8ce0f 61 fields · synced Oct 1, 2026
- FDA UDI b90bbf93-64fc-45b1-bc42-37f471acfb79 36 fields · synced May 30, 2026