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Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000040931

Part of Beijing Biosis Healing Biological Technology Co., Ltd.

Devices
21
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Beijing Biosis Healing Biolog Ical Technology Co., Ltd. makes

The company produces single-use medical barriers and surgical instruments, including nitrile medical gloves, disposable laparoscopic trocars, and specimen retrieval bags. It also manufactures disposable stapling devices—such as linear cutters, endoscopic linear cutters, and reloads for hemorrhoidal and circular staplers—as well as medical surgical gowns and masks. Additionally, it supplies an oral matrix for dental or oral health applications.

These products are regulated under the FDA’s 510(k) pathway, with most falling under Class I or Class II classifications. The company’s devices are listed in the FDA’s 510(k) database, indicating their compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

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  • Vidasis® Ref SIS-HRP-8L-13×15

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-7×20

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-6×11

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-20×20

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Medical Gloves Ref K203622

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Disposable Laparoscope Trocar Ref K201641

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Disposable Specimen Retrieval Bag Ref K201243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads Ref K201639

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medical Surgical Gowns Ref K202844

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oral Matrix Ref K231513

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Medical Surgical Mask Ref K202029

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vidasis® Ref SIS-HRP-8L-6×13

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-13×22

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-2×30

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-7×15

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-10×15

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-20×30

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-2×10

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-3.5×15

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-7×10

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Vidasis® Ref SIS-HRP-8L-2×20

    Active Regimes: CE MDD Registry: EUDAMED Class:III

Rows 1-21 of 21

Company details

EUDAMED SRN
CN-MF-000040931
EUDAMED status
Active
EUDAMED registered name
Beijing Biosis Healing Biological Technology Co., Ltd.
Registered address
No. 29 Yongda Road, 1-2F Building 2，1-2F Building 1, No. 29 Yongda Road, Daxing Bio-medicine Industry Base, Zhongguancun Science Park, Daxing District, Beijing, China, 102600, Beijing, China
PRRC contact
Wang huasheng(public in EUDAMED)

Frequently asked questions

How many devices does Beijing Biosis Healing Biolog Ical Technology Co., Ltd. have in the registry?

The registry currently lists 21 devices for Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Beijing Biosis Healing Biolog Ical Technology Co., Ltd.'s devices?

Among its 21 most recently registered devices, Beijing Biosis Healing Biolog Ical Technology Co., Ltd. has devices listed in EUDAMED (14 devices) and FDA 510(k) (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Beijing Biosis Healing Biolog Ical Technology Co., Ltd.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Beijing Biosis Healing Biolog Ical Technology Co., Ltd.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Beijing Biosis Healing Biolog Ical Technology Co., Ltd. in the registry?

The most recently registered devices listed for Beijing Biosis Healing Biolog Ical Technology Co., Ltd. include Vidasis®, Medical Gloves, Disposable Laparoscope Trocar and Disposable Specimen Retrieval Bag.

Generated automatically from registry data and not verified by a human reviewer.