Shandong Ande Healthcare Apparatus Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000011339 FEI 3012039263
- Devices
- 131
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- MedNet EC-REP GmbHDE
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.
Catalogue
Search and filter all 131 devicesShowing 1-50 of 131
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
- [email protected]
- Phone
- +86 533 3917816
- PRRC contact
- Xiaolei Tian
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 19 Aug 2027
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2352819-1 Expiring
Quality management system EU MDR
- Issued
- 31 Aug 2026
- Expires
- 19 Aug 2027
- Reason
- Other
Frequently asked questions
How many devices does Shandong Ande Healthcare Apparatus Co., Ltd. have in the registry?
The registry currently lists 131 devices for Shandong Ande Healthcare Apparatus Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Ande Healthcare Apparatus Co., Ltd.'s devices?
Among its 50 most recently registered devices, Shandong Ande Healthcare Apparatus Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Shandong Ande Healthcare Apparatus Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shandong Ande Healthcare Apparatus Co., Ltd.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shandong Ande Healthcare Apparatus Co., Ltd.?
EUDAMED lists 1 certificate for Shandong Ande Healthcare Apparatus Co., Ltd. (quality management system) under MDR. The most recent was issued on 31 Aug 2026.
What are the newest devices from Shandong Ande Healthcare Apparatus Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Ande Healthcare Apparatus Co., Ltd. include Arterial Blood Samplers, Nasogastric Feeding Tubes, Midline Catheters and Disposable Sterile Syringes.