Shenzhen Raycome Health Technology Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000033181 FEI 3009690509
- Devices
- 9
- 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.
- Lotus NL B.V.NL
What Shenzhen Raycome Health Technology Co., Ltd makes
Shenzhen Raycome Health Technology Co., Ltd. manufactures medical imaging devices under the Raycome brand, including ultrasound systems designed for diagnostic imaging in clinical settings.
The company’s portfolio is classified under EU Device Class IIa and is registered in the EU’s eudamed database. The manufacturer is based in China.
Catalogue
Raycome Ref BP520DB
Regimes: CE MDR Registry: EUDAMEDRaycome Ref RBP-1100，RBP-1200
Regimes: CE MDR Registry: EUDAMEDRaycome Ref RBP-7000
Regimes: CE MDR Registry: EUDAMEDRaycome Ref BP520D
Regimes: CE MDR Registry: EUDAMEDRaycome Ref RBP-6700/ RBP-6903
Regimes: CE MDD Registry: EUDAMEDRaycome Ref BP-37A/ BP-66A/ BP-88A
Regimes: CE MDD Registry: EUDAMEDRaycome Ref RBP-1100\RBP-1200
Regimes: CE MDD Registry: EUDAMEDRaycome Ref RBP-7000/ RBP-7000B/ RBP-7000W
Regimes: CE MDD Registry: EUDAMEDRaycome Ref RBP-9000/ RBP-9100
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000033181
- FDA FEI number
- 3009690509
- EU VAT number
- 91440300672986933D
- EUDAMED status
- Active
- EUDAMED registered name
- Shenzhen Raycome Health Technology Co.,Ltd
- Registered address
- No.201, Blk 8, Piovan Creative Fty, No.1051, Songbai Rd, Yangguang Community, Xili Street, 518055, Shenzhen, China
- [email protected]
- Phone
- +86-0755-26633519
- PRRC contact
- Peng Zhao
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Feb 2030
DNV MEDCERT GmbH 0482 1 certificate
- 7120GB448260902 Active
Quality management system EU MDR
- Issued
- 2 Sep 2026
- Expires
- 15 Feb 2030
Frequently asked questions
How many devices does SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD have in the registry?
The registry currently lists 9 devices for SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD's devices?
Among its 9 most recently registered devices, SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD has devices listed in EUDAMED (9 devices).
What risk classes do SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD's devices fall under?
Among its 9 most recently registered devices, the classes recorded for SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD?
EUDAMED lists 1 certificate for SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2 Sep 2026.
What are the newest devices from SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD in the registry?
The most recently registered devices listed for SHENZHEN RAYCOME HEALTH TECHNOLOGY CO., LTD include Raycome.