Identity
- Trade Name
- Unodent EUDAMED
- Device Name
- HOLLOWARE EUDAMED
- Model / Reference
- BXS025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G120BXS0250A EUDAMED
- Basic UDI-DI
- ++G120HollowareFF EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS 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
Unodent 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 | ++G120HollowareFF | 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 61c173ed-4832-47db-9ef3-acd8151412a7 61 fields · synced Sep 30, 2026