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Shandong Ande Healthcare Apparatus Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000011339 FEI 3012039263

Devices
131
Registrations
EUDAMEDFDA
FDA recalls
0

What Shandong Ande Healthcare Apparatus Co., Ltd. makes

Shandong Ande Healthcare Apparatus Co., Ltd. makes medical devices such as arterial blood samplers, disposable sterile syringes, closed system transfer devices for single use, and nasogastric feeding tubes. These products are used for various medical purposes, including blood sampling and feeding. The company's portfolio includes devices for single use. The devices are used in healthcare settings.

The company's devices are classified as Class I, Class II, and Class IIa, and are listed in regulatory registries such as Eudamed and FDA 510(k). The company is based in China.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
CN-MF-000011339
FDA FEI number
3012039263
EU VAT number
91370300746575310A
EUDAMED status
Active
EUDAMED registered name
Shandong Ande Healthcare Apparatus Co., Ltd.
Registered address
No. 999, Zunxian Road, New & Hi-Tech Zone, Zunxian Road, New & Hi-Tech Zone, Zibo, 255086 Shandong, P. R. China, 255086, Zibo,Shandong, China
Website
www.andehealthcare.com/en.view/index This address returned "not found" when we last checked — the site may have moved. Last checked 18 Oct 2026.
Phone
+86 533 3917816
PRRC contact
Xiaolei Tian(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 19 Aug 2027

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2352819-1 Expiring Supplemented Expires in 289 days

    Quality management system EU MDR

    Issued
    31 Aug 2026
    Expires
    19 Aug 2027
    Reason
    Other