Identity
- Trade Name
- Unodent EUDAMED
- Device Name
- IMPRESSION TRAYS EUDAMED
- Model / Reference
- IIU215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G120IIU21505 EUDAMED
- Basic UDI-DI
- ++G120ImpressionTrayWJ EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental implant suprastructure, temporary, preformed, single-use
Unodent by Falcon Surgical Co. (Pvt.) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G120ImpressionTrayWJ | Class I | Active |
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Manufacturer
- Manufacturer
- Falcon Surgical Co. (Pvt.) Ltd
- EUDAMED SRN
- PK-MF-000018125
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 277eec1a-bbe3-49df-9e2a-a7def3cf5e76 61 fields · synced Jun 18, 2026