Identity
- Trade Name
- Occlutech Sizing Balloon EUDAMED
- Device Name
- Occlutech Sizing Balloon EUDAMED
- Model / Reference
- 53SB355 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182521854 EUDAMED
- Basic UDI-DI
- 426018252OSBF4 EUDAMED
- Direct Marketing DI
- 04260182521854 EUDAMED
- EMDN Code
- C99 CARDIOCIRCULATORY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Occlutech Sizing Balloon by Occlutech GmbH — Class III — 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 | 426018252OSBF4 | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (1)
- EUDAMED ecf3ab74-21d3-41df-853a-688b6a207c67 61 fields · synced Jun 18, 2026