Avalon Biomed Clear Flex Tips - 20 Pack
FDA UDIEUDAMEDClass I (US FDA UDI)
by Nusmile, Ltd
Identity
- Trade Name
- Avalon Biomed Clear Flex Tip EUDAMEDAvalon Biomed Clear Flex Tips - 20 Pack FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Dental Impression Material Syringe EUDAMEDAvalon Biomed Clear Flex Tips - 20 Pack FDA UDI
- Model / Reference
- Capillary Tip-C EUDAMEDCFT20 FDA UDI
- Description
- Avalon Biomed Clear Flex Tips - 20 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118106538 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001564SEIL05JB EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental material injection cannula, single-use
Avalon Biomed Clear Flex Tips - 20 Pack by Nusmile, Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nusmile, Ltd
Sources (2)
- FDA UDI 9c6a2933-bdd3-497a-a167-ea8979524f74 33 fields · synced Jul 10, 2026
- EUDAMED f3b95b5b-3e49-4143-b413-f4085df17ee5 61 fields · synced Jul 10, 2026