Identity
- Trade Name
- VALVEVAULT® DEVICE (S) 19MM / 21MM EUDAMEDVALVEVAULT™ FDA UDI
- Generic Name
- Heart valve prosthesis holder, reusable FDA UDI
- Device Name
- VALVEVAULT® DEVICE (S) 19MM / 21MM EUDAMEDVALVEVAULT™ DEVICE (S) 19mm / 21mm FDA UDI
- Model / Reference
- 081025 EUDAMEDFDA UDI
- Description
- VALVEVAULT™ DEVICE (S) 19mm / 21mm FDA UDI
Identifiers
- Catalog Number
- 081025 FDA UDI
- Primary DI / UDI-DI
- 00850012846055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850012846055 EUDAMED0850012846VALVEVAULTDD EUDAMED
- Direct Marketing DI
- 00850012846055 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 (s) 19mm / 21mm by LSI Solutions, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00850012846055 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00850012846055 | 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 31127dc7-258d-4949-9086-0f49f10a40fd 61 fields · synced Jun 19, 2026
- EUDAMED 6ad4d189-3f0d-4d95-af6b-7caea5f794b3 61 fields · synced May 19, 2026
- FDA UDI 7a4c8c61-a9de-4562-a17e-5604ecba677d 36 fields · synced May 30, 2026