Micro-Energy Medical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000050470 FEI 3042261306
- Devices
- 16
- 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
What Micro-Energy Medical Technology Co., Ltd. makes
Micro-Energy Medical Technology Co., Ltd. manufactures single-use radial fibers for medical laser applications, including the Halo and Novo series, and a diode laser system (Model: Halo) designed for surgical procedures. The radial fibers are intended for flexible delivery of laser energy in minimally invasive surgeries, while the SurgiLight system provides a handheld laser source for precision cutting and coagulation.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory authorisation in the United States. The manufacturer operates from the US.
Catalogue
Search and filter all 16 devicesCompany details
- EUDAMED SRN
- CN-MF-000050470
- FDA FEI number
- 3042261306
- DUNS number
- 620289544
- EUDAMED status
- Active
- EUDAMED registered name
- Micro-Energy Medical Technology Co., Ltd.
- Registered address
- No. 13, Section B4301, B4701 and B4901, No. 13, Baolan Road, Kengzi Street, Pingshan District, 518118, Shenzhen, China
- [email protected]
- PRRC contact
- Sha Xu
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 22 Jun 2031
DNV Product Assurance AS 2460 1 certificate
- C733383 Active
Quality management system EU MDR
- Issued
- 23 Jun 2026
- Expires
- 22 Jun 2031
Frequently asked questions
How many devices does Micro-Energy Medical Technology Co., Ltd. have in the registry?
The registry currently lists 16 devices for Micro-Energy Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro-Energy Medical Technology Co., Ltd.'s devices?
Among its 16 most recently registered devices, Micro-Energy Medical Technology Co., Ltd. has devices listed in EUDAMED (3 devices), FDA 510(k) (3 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Micro-Energy Medical Technology Co., Ltd.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Micro-Energy Medical Technology Co., Ltd.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Micro-Energy Medical Technology Co., Ltd.?
EUDAMED lists 1 certificate for Micro-Energy Medical Technology Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 23 Jun 2026.
What are the newest devices from Micro-Energy Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Micro-Energy Medical Technology Co., Ltd. include SurgiLight 1470 Diode Laser System Halo, Halo Sterile Single-use Radial Fiber Novo-R-0.40-1.8, Halo Sterile Single-use Radial Fiber Novo-R-0.60-1.8 and Hemolase Fiber Hemo-R-0.40-2.5.