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Shenzhen Witleaf Medical Electronics Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000040494 FEI 3020924771

Devices
90
Registrations
EUDAMEDFDA
FDA recalls
0

What Shenzhen Witleaf Medical Electronics Co., Ltd. makes

Shenzhen Witleaf Medical Electronics Co., Ltd. manufactures single-use nasopharyngeal airways and a range of patient monitors designed for respiratory and vital sign monitoring. The patient monitors track physiological parameters such as heart rate, oxygen saturation, and breathing patterns, supporting clinical and home-use applications. The company also provides a dedicated children’s respiration monitor tailored for pediatric patients.

The nasopharyngeal airway falls under Class I regulation, while the patient monitors are classified as Class IIa or Class IIb depending on their features. These devices are listed in the EU’s EUDAMED registry and the FDA’s UDI system. The company is based in China.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue90

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  • Patient Monitor Ref W15A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F1B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref EK12

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F18B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref W15B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F12A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L12B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F12

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L15J

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L15B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref XH-60F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F18

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref W12C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F15

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L15

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref F1C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref EK10Q

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref W12B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref EK12P

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L12C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L12Q

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref L15P

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Patient Monitor Ref EK12K

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • iWay iway 15

    None Registry: GUDID Class:I

  • iWay iway 13

    None Registry: GUDID Class:I

  • Rapid Intervention Capnograph Ref RICap

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • Fingertip Pulse Oximeter Ref WIT-S200

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Handheld Pulse Oximeter Ref WIT-S300

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Patient Monitor Ref XH-60C

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref XH-30D

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref SPLF-OX

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref SATP-SE

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref SPLF-MC

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref XH-30A

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Fingertip Pulse Oximeter Ref WIT-S400

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED Class:IIa

  • Patient Monitor Ref XH-30C

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Handheld Pulse Oximeter Ref WIT-S100

    Active Regimes: CE MDD 510(k) Registry: EUDAMED Class:IIa

  • Patient Monitor Ref SPLF-NP

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref SPLF-SE

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref XH-60A

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Rows 51-90 of 90

Showing 51-90 of 90

Company details

EUDAMED SRN
CN-MF-000040494
FDA FEI number
3020924771
DUNS number
403635526
EUDAMED status
Active
EUDAMED registered name
Shenzhen Witleaf Medical Electronics Co., Ltd
EUDAMED abbreviated name
Witleaf
Registered address
Room 1201, Building 1, Senyang Electronic Technology Park, West Area,, 518132, Shenzhen, China
Phone
+86 (0)755-21384132
PRRC contact
Tyler Wu(public in EUDAMED)