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LipAlign
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref LAT-MModel LAT-S, LAT-M, LAT-LRef LAT-SRef LAT-L
Identity
- Trade Name
- LipAlign FDA UDI
- Generic Name
- Skin-closure adhesive strip FDA UDI
- Device Name
- LipAlign EUDAMEDCleft Lip Approximation Tape Size Small FDA UDICleft Lip Approximation Tape Size Large FDA UDICleft Lip Approximation Tape Size Medium FDA UDI
- Model / Reference
- LAT-S EUDAMEDFDA UDILAT-L EUDAMEDFDA UDILAT-M EUDAMEDFDA UDILAT-S, LAT-M, LAT-L EUDAMED
- Description
- Cleft Lip Approximation Tape Size Small FDA UDICleft Lip Approximation Tape Size Large FDA UDICleft Lip Approximation Tape Size Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010953952 EUDAMEDFDA UDI00860010953938 EUDAMEDFDA UDI00860010953945 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600109539LATQ7 EUDAMED
- FDA Product Code
- MZR FDA UDI
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
- GMDN Term
- Skin-closure adhesive strip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-closure adhesive strip
LipAlign by Cleftalign Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Skin-closure adhesive strip.
- UC Strip™ — Derma Sciences Canada, Inc · Class I
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- Suture Strip® — Derma Sciences Canada, Inc · Class I
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- BContak — BRIDON, CORP. · Class III
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- CareOne — Ahold U.S.A., Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cleftalign Inc.
Sources (6)
- FDA UDI 415bec6e-f435-4292-be4e-8c712fffd104 33 fields · synced Jul 24, 2026
- FDA UDI 13cb1b61-fe36-4514-9c83-a34bc0d671c9 33 fields · synced May 30, 2026
- FDA UDI 2afe7542-a8a2-4adb-9d73-b66b4e0a753a 33 fields · synced May 30, 2026
- EUDAMED 9d0ceaed-9107-4b61-ba5e-2e4986110b29 61 fields · synced Jul 11, 2026
- EUDAMED 671fc218-4b22-495a-bbcf-48d3d2e75008 61 fields · synced Jul 18, 2026
- EUDAMED e00e8b92-1a2f-4ea9-a884-af141752d741 61 fields · synced Jul 24, 2026