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inSafe Syringe, 2.2ml, Harpoon Asp., Thumb Ring - Astek
EUDAMEDFDA UDIClass I (EU MDR)
Ref 23013ASTEK
Identity
- Trade Name
- inSafe Syringe, 2.2ml, Harpoon Asp., Thumb Ring - Astek EUDAMEDAstek FDA UDI
- Generic Name
- Dental anaesthesia injection kit FDA UDI
- Device Name
- inSafe Safety Syringe System EUDAMEDinSafe Syringe, 2.2ml, Harpoon Asp., Thumb Ring - Astek FDA UDI
- Model / Reference
- 23013ASTEK EUDAMEDFDA UDI
- Description
- inSafe Syringe, 2.2ml, Harpoon Asp., Thumb Ring - Astek FDA UDI
Identifiers
- Catalog Number
- 23013ASTEK FDA UDI
- Primary DI / UDI-DI
- 10840326421892 EUDAMED00840326421895 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 Syringe, 2.2ml, Harpoon Asp., Thumb Ring - 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 | 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 4f957eb0-5779-4abd-ab8e-f60c28dba110 61 fields · synced Jul 23, 2026
- FDA UDI 9cc5cd29-3d96-478c-8083-1b25bb15dbff 36 fields · synced May 30, 2026