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MemoPart™
EUDAMEDClass III (EU MDR)
Ref P/V-12FModel ASD-6F, ASD-7F, ASD-8F, ASD-9F, ASD-10F, ASD-12F, ASD-14F, P/V-6F, P/V-7F, P/V-8F, P/V-9F, P/V-10F, P/V-12F, P/V-14F
Identity
- Trade Name
- MemoPart™ EUDAMED
- Device Name
- Sterile Disposable MemoPart™ Occluder Delivery System II EUDAMED
- Model / Reference
- ASD-6F, ASD-7F, ASD-8F, ASD-9F, ASD-10F, ASD-12F, ASD-14F, P/V-6F, P/V-7F, P/V-8F, P/V-9F, P/V-10F, P/V-12F, P/V-14F EUDAMEDP/V-12F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933052358123 EUDAMED
- Basic UDI-DI
- 69330523XZ0007KD EUDAMED
- EMDN Code
- P07040399 HEART AND CORONARY DEFECT OCCLUDERS - 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
MemoPart™ by Shanghai Shape Memory Alloy Co., Ltd. — 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 | 69330523XZ0007KD | Class III | Active |
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Manufacturer
- Manufacturer
- Shanghai Shape Memory Alloy Co., Ltd.
- EUDAMED SRN
- CN-MF-000008245
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 3a685e21-a1d8-48ab-8461-4e3fe17896da 61 fields · synced Jun 18, 2026