Identity
- Trade Name
- Gaumenbolus Mundkeil Large EUDAMED
- Device Name
- Gaumenbolus EUDAMED
- Model / Reference
- P10107-627 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120074396272 EUDAMED
- Basic UDI-DI
- 91200743953M8 EUDAMED
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Gaumenbolus Mundkeil Large by IT-V Medizintechnik GmbH — 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 | 91200743953M8 | Class I | Active |
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Manufacturer
- Manufacturer
- IT-V Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000001918
Sources (1)
- EUDAMED 0b91605d-6537-4f14-8a32-f7e80c1dfe50 61 fields · synced Jun 18, 2026