Shanghai Bolan Optical Electric Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000036896 FEI 3033858960
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Lotus NL B.V.NL
- Authorised rep.
- SUNGO Europe B.V.NL
What Shanghai Bolan Optical Electric Co., Ltd makes
Shanghai Bolan Optical Electric Co., Ltd manufactures slit lamp microscopes, including portable and stationary models, designed for ophthalmic examinations. Their product line also includes a handheld device referred to as the BOLAN, which appears to serve similar diagnostic purposes in eye care settings.
The company’s devices are classified under Class I and Class II regulatory categories, with listings in the EU’s eudamed registry and the FDA’s 510(k) database. The manufacturer is based in China.
Catalogue
Portable Slit Lamp Ref K153545
CE MDD 510(k) 510(k)Slit Lamp Microscope Ref BL-99D
CE MDR EUDAMEDBolan Ref 30102309
CE MDD EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000036896
- FDA FEI number
- 3033858960
- EU VAT number
- 913101187402957052
- EUDAMED status
- Active
- EUDAMED registered name
- Shanghai Bolan Optical Electric Co., Ltd
- Registered address
- No. 29, Jiuyuan Road ,Qingpu District, 201712, shanghai, China
- Website
- www.sh-bolan.com
- [email protected]
- Phone
- +86 13641690009
- PRRC contact
- ZHONGLI HU
From the company website
SHANGHAI X-RAYS FOR OPTICAL DEVICES SUCH AS CLEAVAGE LIGHT MICROSCOPES, DIGITAL CLEAVAGE LIGHT MICROSCOPES, HAND-HELD CLEAVAGE LIGHT MICROSCOPES, ANGULAR CURVATURE CURVOMETERS, VISION PROJECTOR, ETC. THERE ARE A NUMBER OF COMPREHENSIVE TYPES, SUCH AS BL-66B, BL-6A, BL-5000, AND BL-88D。
Frequently asked questions
How many devices does Shanghai Bolan Optical Electric Co., Ltd have in the registry?
The registry currently lists 3 devices for Shanghai Bolan Optical Electric Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Bolan Optical Electric Co., Ltd's devices?
Among its 3 most recently registered devices, Shanghai Bolan Optical Electric Co., Ltd has devices listed in EUDAMED (2 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shanghai Bolan Optical Electric Co., Ltd's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Shanghai Bolan Optical Electric Co., Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Bolan Optical Electric Co., Ltd in the registry?
The most recently registered devices listed for Shanghai Bolan Optical Electric Co., Ltd include Portable Slit Lamp, Slit Lamp Microscope and BOLAN.