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CoralView
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref U10-BModel U10, U10-B, U10-BR, U20, U20-B, U20-BRRef U20-BRRef U20-BRef U10-BRRef U10
Identity
- Trade Name
- CoralView EUDAMEDFDA UDICoralView® FDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- Single-Use Digital Flexible Ureteroscope EUDAMEDCoralView®, Single-Use Digital Flexible Ureteroscope, U10-B FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U10 FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U10-BR FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U20-B FDA UDI
- Model / Reference
- U10 EUDAMEDFDA UDIU10-B EUDAMEDFDA UDIU20-BR EUDAMEDFDA UDIU10-BR EUDAMEDFDA UDIU20-B EUDAMEDFDA UDIU10, U10-B, U10-BR, U20, U20-B, U20-BR EUDAMED
- Description
- CoralView®, Single-Use Digital Flexible Ureteroscope, U10-B FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U10 FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U10-BR FDA UDICoralView®, Single-Use Digital Flexible Ureteroscope, U20-B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975339620684 EUDAMEDFDA UDI06975339620691 EUDAMEDFDA UDI06975339620318 EUDAMEDFDA UDI06975339620301 EUDAMEDFDA UDI06975339620738 EUDAMEDFDA UDI06975339620325 EUDAMEDFDA UDI06975339620349 EUDAMEDFDA UDI06975339620363 EUDAMED06975339620370 EUDAMED06975339620387 EUDAMED
- Basic UDI-DI
- 697533962001MJ EUDAMED
- 510(k) Number
- K231774 FDA UDI
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Flexible video ureteroscope, single-use
CoralView by MacroLux Medical Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MacroLux Medical Technology Co., Ltd.
Sources (17)
- FDA UDI 059725e1-09d7-401c-82da-5a812b91bb3c 32 fields · synced Aug 5, 2026
- FDA UDI cc63f6ad-df39-442d-b370-b8c69f29f0e4 32 fields · synced May 29, 2026
- FDA UDI 6e616549-83ef-4439-99c4-6880c8d291ef 34 fields · synced May 30, 2026
- FDA UDI c6f24c22-a314-4c10-94c2-36019830f79d 34 fields · synced May 30, 2026
- FDA UDI ab12947e-7711-4089-bdc4-02ba4834c867 32 fields · synced May 30, 2026
- FDA UDI 52df91fc-b1d8-445e-a062-1d158ea3ade4 34 fields · synced May 30, 2026
- FDA UDI 3c219cfe-5118-43ec-a83e-2f447fa01f7e 34 fields · synced May 30, 2026
- EUDAMED 367dd40c-4e39-4065-bc56-d5d2b4d6a783 61 fields · synced Jul 12, 2026
- EUDAMED 22721daf-2d28-4b4d-a707-218ec954c2ff 61 fields · synced Jul 13, 2026
- EUDAMED f10e70ae-75e2-488c-8ba9-a7e52b8b4929 61 fields · synced Jul 19, 2026
- EUDAMED 7e912c8b-9647-4d31-aea1-9369ed42c688 61 fields · synced Jul 24, 2026
- EUDAMED 22acb044-d9c5-4b9c-8fc3-d182011d38d1 61 fields · synced Jul 27, 2026
- EUDAMED cd14a8e4-ce70-4b43-b606-775de9cf4ff9 61 fields · synced Jul 30, 2026
- EUDAMED 820429fa-8c78-4bb7-817a-7fec7e822a9a 61 fields · synced Jul 31, 2026
- EUDAMED f6bb77a3-bdbd-4ef9-a408-0415c5651b39 61 fields · synced Aug 2, 2026
- EUDAMED f9b62a5d-bc81-40be-a787-1cdd079f7b6c 61 fields · synced Aug 3, 2026
- EUDAMED 9b6a37c0-aa6b-4447-aa25-73dec9fdeab3 61 fields · synced Aug 5, 2026