Identity
- Trade Name
- GAF EUDAMED
- Device Name
- GAF EUDAMED
- Model / Reference
- M601D001T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640153260093 EUDAMED
- Basic UDI-DI
- B-07640153260093 EUDAMED
- EMDN Code
- G05 TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Gaf by MDT Int'l SA — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640153260093 | Class III | Active |
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Manufacturer
- Manufacturer
- MDT Int'l SA
- EUDAMED SRN
- CH-MF-000028146
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 9dd13d03-1d15-4fdc-a07c-1def84a0e955 61 fields · synced Jun 19, 2026