← Back to catalogue

Single-Use Video Flexible Cysto-Nephroscope

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref RP-U-C01FModel RP-U-C01F, RP-U-C01FS, RP-U-C01E, RP-U-C01ES

by Guangzhou Red Pine Medical Instrument Co., Ltd.

Identity

Trade Name
REDPINE FDA UDI
Generic Name
Flexible video cystonephroscope, single-use FDA UDI
Device Name
Single-Use Video Flexible Cysto-Nephroscope EUDAMED
Model / Reference
RP-U-C01F, RP-U-C01FS, RP-U-C01E, RP-U-C01ES EUDAMED
RP-U-C01F EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06972520300561 EUDAMEDFDA UDI
Basic UDI-DI
697252030CYSF02GD EUDAMED
510(k) Number
K241500 FDA UDI
FDA Product Code
FAJ FDA UDI
EMDN Code
Z12020705 NEPHROSCOPES EUDAMED
GMDN Term
Flexible video cystonephroscope, 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

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 (3)

  • EUDAMED f39a4aeb-6424-495a-a6e3-19f155f2a1c0 61 fields · synced Jul 20, 2026
  • FDA UDI 8f632a4c-5b86-47c0-82c4-e4afb8fa5282 33 fields · synced May 29, 2026
  • FDA 510(k) K252176 1 fields · synced May 18, 2026