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Valvevault® Device (l) 27mm / 29mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 081035Model 081025
Identity
- Trade Name
- VALVEVAULT® DEVICE (L) 27MM / 29MM EUDAMEDVALVEVAULT™ FDA UDI
- Generic Name
- Heart valve prosthesis holder, reusable FDA UDI
- Device Name
- VALVEVAULT® DEVICE (S) 19MM / 21MM EUDAMEDVALVEVAULT® DEVICE (L) 27MM / 29MM EUDAMEDVALVEVAULT™ DEVICE (L) 27mm / 29mm FDA UDI
- Model / Reference
- 081025 EUDAMED081035 EUDAMEDFDA UDI
- Description
- VALVEVAULT™ DEVICE (L) 27mm / 29mm FDA UDI
Identifiers
- Catalog Number
- 081035 FDA UDI
- Primary DI / UDI-DI
- 00850012846079 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850012846VALVEVAULTDD EUDAMEDB-00850012846079 EUDAMED
- Direct Marketing DI
- 00850012846079 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- L07080699 CARDIOVASCULAR PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Heart valve prosthesis holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Valvevault® Device (l) 27mm / 29mm by LSI Solutions, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0850012846VALVEVAULTDD | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850012846VALVEVAULTDD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LSI SOLUTIONS, Inc.
- EUDAMED SRN
- US-MF-000008267
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 85a8d4b7-9922-4cf5-89e1-2ced709f23db 61 fields · synced Jun 19, 2026
- EUDAMED 582fb253-b352-4b91-8868-ae359805d5ad 61 fields · synced May 18, 2026
- FDA UDI 5c40b5f9-b4d0-4a50-bc38-4d66044065a3 36 fields · synced May 30, 2026