Identity
- Trade Name
- inSafe Sharps Container - Astek EUDAMEDAstek FDA UDI
- Generic Name
- Dental anaesthesia injection kit FDA UDI
- Device Name
- inSafe Safety Syringe System EUDAMEDinSafe Sharps Container ? Astek FDA UDI
- Model / Reference
- 23050ASTEK EUDAMEDFDA UDI
- Description
- inSafe Sharps Container ? Astek FDA UDI
Identifiers
- Catalog Number
- 23050ASTEK FDA UDI
- Primary DI / UDI-DI
- 10840326421984 EUDAMED00840326421987 FDA UDI
- Basic UDI-DI
- 0840326445152EJIAS 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
- Ireland 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
Yes
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
Yes
EUDAMED
Measuring Function
Yes
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 Sharps Container - Astek by Young Innovations, Inc. — 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 | 0840326445152EJIAS | 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
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8030201b-fb98-4b69-8d7f-4229f6062c7c 61 fields · synced Jun 18, 2026
- FDA UDI 47b45ef5-e884-46cf-b554-6437252f194b 36 fields · synced May 30, 2026