WONTECH Surgical Optic Fibers
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- WONTECH Surgical Optic Fibers FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Surgical Optical Fiber EUDAMEDBA400R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R) FDA UDI
- Model / Reference
- BA400R EUDAMEDFDA UDISurgical Optical Fiber BA400R EUDAMED
- Description
- BA400R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800022301824 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800022301824 EUDAMED
- 510(k) Number
- K241643 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Slovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General/multiple surgical laser system beam guide, single-use
WONTECH Surgical Optic Fibers by Wontech Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wontech Co., Ltd
Sources (2)
- FDA UDI 51134e8d-155c-4cd3-b3d3-316ea196fd9b 34 fields · synced Jul 16, 2026
- EUDAMED 4f895426-ac3a-43e8-8f87-714365c183eb 61 fields · synced Jul 16, 2026