Identity
- Trade Name
- LeMaitre® Stent Guide EUDAMEDVascuTape Radiopaque Tape FDA UDI
- Generic Name
- X-ray film ruler FDA UDI
- Device Name
- VascuTape Radiopaque Tape EUDAMEDLemaitre Stent Guide (100 Strips) FDA UDI
- Model / Reference
- 1102-00 EUDAMEDFDA UDI
- Description
- Lemaitre Stent Guide (100 Strips) FDA UDI
Identifiers
- Catalog Number
- 1102-00 FDA UDI
- Primary DI / UDI-DI
- 00840663100354 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840663100354 EUDAMED
- 510(k) Number
- K932184 FDA UDI
- FDA Product Code
- KFX FDA UDI
- EMDN Code
- V030201 CALIPERS EUDAMED
- GMDN Term
- X-ray film ruler FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3500 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
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
LeMaitre® Stent Guide by LeMaitre Vascular, Inc. — Class I — 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-00840663100354 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 9a9c340a-2b38-4c79-b93b-65eeb417688d 61 fields · synced Jun 19, 2026
- FDA UDI 7a450aad-8283-49e8-a18a-f2b148bfb81f 36 fields · synced May 30, 2026