Identity
- Trade Name
- STERINORM® Rund-Haube EUDAMED
- Device Name
- Haube und Beutel EUDAMED
- Model / Reference
- 38080 EUDAMED38140 EUDAMED38125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251806201054 EUDAMED04251806201092 EUDAMED04251806201085 EUDAMED
- Basic UDI-DI
- 42518062005L6 EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I 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
Category: Vascular booties
STERINORM® Rund-Haube by Udo Heisig GmbH The Disposables Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 42518062005L6 | Class I | Active |
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Manufacturer
- Manufacturer
- Udo Heisig GmbH The Disposables Company
- EUDAMED SRN
- DE-MF-000009334
Sources (3)
- EUDAMED ae2baf9a-877b-4f6d-b3af-2a49e65d830f 61 fields · synced Jul 26, 2026
- EUDAMED fa017332-ccac-4573-a0d8-9d115a77a9b6 61 fields · synced May 18, 2026
- EUDAMED cf3b3bf8-61b2-454e-868c-0abcddb88461 61 fields · synced May 19, 2026