Single-Use Video Flexible Ureterorenoscope

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref RP-U-C04R9Model RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3Ref RP-U-C0304R3Model RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305BRef RP-U-C03R9Ref RP-U-C03S9Ref RP-U-C0306FS9Model RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS9Ref RP-U-C04R3Ref RP-U-C03R3Ref RP-U-C0305BRef RP-U-C04S9Ref RP-U-C12S9Ref RP-U-C0305Ref RP-U-C03S3

by Guangzhou Red Pine Medical Instrument Co., Ltd.

Identity

Trade Name: Single-Use Video Flexible Ureterorenoscope EUDAMED
REDPINE FDA UDI
Generic Name: Flexible video ureterorenoscope, single-use FDA UDI
Device Name: Single-Use Video Flexible Ureterorenoscope EUDAMED
Model / Reference: RP-U-C03R9, RP-U-C03S9, RP-U-C03R3, RP-U-C03S3, RP-U-C04R9, RP-U-C04S9, RP-U-C04R3, RP-U-C04S3 EUDAMED
RP-U-C04R9 EUDAMED
RP-U-C12, RP-U-C0304, RP-U-C0305, RP-U-C12S3, RP-U-C12S9, RP-U-C12R3, RP-U-C0304S3, RP-U-C0304S9, RP-U-C0304R3, RP-U-C0305S3, RP-U-C0305S9, RP-U-C0305R3, RP-U-C12., RP-U-C12K, RP-U-C0305B EUDAMED
RP-U-C0304R3 EUDAMEDFDA UDI
RP-U-C03R9 EUDAMED
RP-U-C03S9 EUDAMED
RP-U-C0306F, RP-U-C0307F, RP-U-C0306FS9, RP-U-C0307FS9 EUDAMED
RP-U-C0306FS9 EUDAMED
RP-U-C04R3 EUDAMED
RP-U-C03R3 EUDAMED
RP-U-C0305B EUDAMED
RP-U-C04S9 EUDAMED
RP-U-C12S9 EUDAMEDFDA UDI
RP-U-C0305 EUDAMED
RP-U-C03S3 EUDAMED

Identifiers

Primary DI / UDI-DI: 06972520302022 EUDAMED
06972520300851 EUDAMEDFDA UDI
06972520301759 EUDAMED
06972520301766 EUDAMED
06972520301353 EUDAMED
06972520302060 EUDAMED
06972520301773 EUDAMED
06972520302152 EUDAMED
06972520302046 EUDAMED
06972520300820 EUDAMEDFDA UDI
06972520301629 EUDAMED
06972520301780 EUDAMED
Basic UDI-DI: 697252030UREF03JA EUDAMED
697252030UREF01J6 EUDAMED
697252030UREF02J8 EUDAMED
510(k) Number: K221158 FDA UDI
FDA Product Code: FGB FDA UDI
EMDN Code: Z12020713 URETERORENOSCOPES EUDAMED
GMDN Term: Flexible video ureterorenoscope, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video ureteroscope, single-use

Single-Use Video Flexible Ureterorenoscope by Guangzhou Red Pine Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…

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
CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
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

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K251951	Class IIa	Active
EUDAMED	European Union	CE/MDR	697252030UREF03JA	Class IIa	Active

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Manufacturer

Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.
EUDAMED SRN: CN-MF-000012833
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (15)

EUDAMED 510a1638-f383-4cb7-9b6c-90dfe2dd349c 61 fields · synced Aug 4, 2026
EUDAMED 680739da-84a6-4792-b738-0a3fa2947c2f 61 fields · synced May 17, 2026
EUDAMED c389e729-639b-4107-a000-eab0c6f63a4e 61 fields · synced May 17, 2026
EUDAMED fe77d70e-b172-414b-baf3-1149f4a67698 61 fields · synced May 18, 2026
EUDAMED bf7e514c-430c-4437-8ff5-7a65690c7601 61 fields · synced May 18, 2026
EUDAMED 2bd62fcb-ed48-4c91-84c7-e7f063dafcb5 61 fields · synced May 18, 2026
EUDAMED d9de29af-85ed-41e2-9d1f-8dec34befb39 61 fields · synced May 18, 2026
EUDAMED b6e7d53c-c5f1-4a0c-8c67-e79f3a8d90cd 61 fields · synced May 18, 2026
EUDAMED 5ebf60ab-b719-4e89-9360-f6294b4d61ae 61 fields · synced May 18, 2026
FDA UDI 63a12c1b-c948-4b04-8bc5-00f30cd8b42d 33 fields · synced May 30, 2026
FDA UDI 6d82f09f-6d13-4657-b383-462f951b927b 33 fields · synced May 30, 2026
EUDAMED 3e0cf0a1-2fee-4462-b2ea-2c169d4ae5f8 61 fields · synced Jul 18, 2026
EUDAMED 00f0d078-15ba-4243-b152-1ea3e689c9c8 61 fields · synced Jul 20, 2026
EUDAMED 62555edd-f694-473d-9441-c604476ccb9c 61 fields · synced Jul 26, 2026
FDA 510(k) K251951 1 fields · synced May 18, 2026