Identity
- Trade Name
- Infacol EUDAMED
- Device Name
- Infacol Simeticone EUDAMED
- Model / Reference
- 307356 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-307356NR EUDAMED
- Basic UDI-DI
- B-307356NR EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Infacol by Merckle GmbH — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-307356NR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Merckle GmbH
- EUDAMED SRN
- DE-MF-000018230
Sources (1)
- EUDAMED 89c1473f-49f7-4d9d-8376-4ea35cfaa2ae 61 fields · synced Jul 19, 2026