Identity
- Trade Name
- Blue Micro Tips EUDAMEDBlue Micro Tip FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDISyringe tip cap FDA UDI
- Device Name
- Tips EUDAMEDBlue Micro Tips 20pk FDA UDIBlue Micro Tips 500pk FDA UDIBlue Micro Tips 100pk FDA UDI
- Model / Reference
- 158 EUDAMEDFDA UDI127 EUDAMEDFDA UDI1436 EUDAMEDFDA UDI
- Description
- Blue Micro Tips 20pk FDA UDIBlue Micro Tips 500pk FDA UDIBlue Micro Tips 100pk FDA UDI
Identifiers
- Catalog Number
- 158 FDA UDI1436 FDA UDI127 FDA UDI
- Primary DI / UDI-DI
- 00883205021618 EUDAMEDFDA UDI00883205021595 EUDAMEDFDA UDI00883205022394 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF032AQ EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDISyringe tip cap FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Category: Dental material injection cannula, single-use
Blue Micro Tips by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0883205-TF032AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
- EUDAMED SRN
- US-MF-000013697
- Authorised Representative
- Ultradent Products GmbH DE-AR-000006666
Sources (9)
- EUDAMED df9a2878-4905-4668-9e92-4fdf2db92a04 61 fields · synced Jul 31, 2026
- EUDAMED f6697ca7-abda-4147-8628-609eb2394c1c 61 fields · synced May 17, 2026
- EUDAMED 1d61476e-e648-4fd9-b735-b17bea7cd46d 61 fields · synced May 17, 2026
- FDA UDI 0ced7393-d70a-46bf-b4c3-ac38c6491682 35 fields · synced May 24, 2026
- FDA UDI dfafdce8-7696-4c42-aaf3-3e9531ee4f19 35 fields · synced May 29, 2026
- FDA UDI 297fcdf0-fd2a-480e-8a35-0b8eccce18a7 35 fields · synced May 30, 2026
- EUDAMED 1dec2d94-240b-42f6-950b-c5fabfbac734 61 fields · synced Jul 10, 2026
- EUDAMED b87b3c66-a1a8-4a29-8622-ceba40fdccec 61 fields · synced Jul 31, 2026
- EUDAMED bc38c348-5ec9-404c-a19a-63ca32d7f829 61 fields · synced Jul 31, 2026