Identity
- Trade Name
- XenoSure® Biologic Patch EUDAMEDXenoSure Biologic Patch FDA UDI
- Generic Name
- Cardiovascular patch, animal-derived FDA UDI
- Device Name
- Xenosure Biologic Patch EUDAMEDXenoSure Biologic Patch, 1cmx10cm FDA UDI
- Model / Reference
- 1BV10 EUDAMEDFDA UDI
- Description
- XenoSure Biologic Patch, 1cmx10cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840663106097 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840663106097 EUDAMED
- 510(k) Number
- K040835 FDA UDI
- FDA Product Code
- FTM FDA UDI
- EMDN Code
- P07020101 PERICARDIUM VASCULAR PATCHES EUDAMED
- GMDN Term
- Cardiovascular patch, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
XenoSure® Biologic Patch by LeMaitre Vascular, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840663106097 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
- EUDAMED SRN
- US-MF-000016778
- Authorised Representative
- LeMaitre Vascular GmbH DE-AR-000013539
Sources (2)
- EUDAMED 9cd65af8-d0e8-4f25-8ea3-4d3eba4ab4dc 61 fields · synced Aug 4, 2026
- FDA UDI dcc74187-7310-46f1-9e31-980b72dac60c 34 fields · synced May 30, 2026