Identity
- Trade Name
- Au6802021HKSH00 EUDAMED
- Device Name
- Anteris Ultra EUDAMED
- Model / Reference
- Au6802021HKSH00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060928391647 EUDAMED
- Basic UDI-DI
- 506041344ANTE3X EUDAMED
- Direct Marketing DI
- 05060928391647 EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Au6802021HKSH00 by Brandon Medical Company Limited — 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 | 506041344ANTE3X | Class I | Active |
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Manufacturer
- Manufacturer
- Brandon Medical Company Limited
- EUDAMED SRN
- GB-MF-000005501
- Authorised Representative
- RegTrac Limited IE-AR-000042448
Sources (1)
- EUDAMED 76ed8c8d-9950-4a49-8a5e-7bfafd5d8d64 61 fields · synced Oct 6, 2026