Identity
- Trade Name
- Apex EUDAMED
- Device Name
- SPATULAS EUDAMED
- Model / Reference
- 2SEKO450500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G1202SEKO4505000X EUDAMED
- Basic UDI-DI
- ++G120SpatulasTS EUDAMED
- EMDN Code
- L1504 ODONTOSTOMATOLOGY MODELERS, REUSABLE 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
Apex by Falcon Surgical Co. (Pvt.) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++G120SpatulasTS | 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 b22417b9-d5d0-4223-bdf1-2af5c95ac71c 61 fields · synced Sep 18, 2026