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IVeneer injectable matrix system
EUDAMEDFDA UDIClass I (EU MDR)
Ref IVEL64
by Iveneer Ltd.
Identity
- Trade Name
- IVeneer Injectable Matrix System FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- IVeneer injectable matrix system EUDAMED
- Model / Reference
- IVEL64 EUDAMEDIntro Kit 64 size M/L FDA UDI
Identifiers
- Catalog Number
- IVEL64 FDA UDI
- Primary DI / UDI-DI
- 07290019259015 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290019259IVEF128FP EUDAMED
- Direct Marketing DI
- 07290019259015 EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
IVeneer injectable matrix system by Iveneer Ltd — 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 | 7290019259IVEF128FP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Iveneer Ltd.
- EUDAMED SRN
- IL-MF-000024475
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (2)
- EUDAMED 6545b2b1-9935-4f05-a856-0fafaf0794a8 61 fields · synced May 30, 2026
- FDA UDI 29878e09-e726-42e1-85a4-9e9122b95715 35 fields · synced May 30, 2026