Emsrun Group
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000037456 FEI 3012777736
Emsrun Group is a medical device manufacturer based in China, with 173 devices listed in FDA GUDID and EUDAMED (FDA Class I; EU Class I and IIa) as of 12 Nov 2026.
- Devices
- 173
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 122
- EUDAMED 59
- Device classes
- FDA Class I 115
- EU Class I 47
- EU Class IIa 11
- Top EMDN categories
- Sites and related companies
- Sungo Cert GmbH authorised representative
- Identifiers
- EUDAMED SRN CN-MF-000037456
- FDA FEI 3012777736
- DUNS 712452198
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Sungo Cert GmbHDE
What Emsrun Group makes
The manufacturer produces reusable and single-use first aid and wound care products, including absorbent pads, bandage scissors, synthetic polymer burn dressings, and limb tourniquets. Their portfolio also covers reusable scar-management dressings, non-medicated reusable first aid kits, and non-latex pressure bandages. Woven gauze rolls and sheets are also part of their offerings.
These devices are classified as Class I or Class IIa under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The company operates from China.
Catalogue
Search and filter all 173 devicesShowing 1-50 of 173
Company details
- EUDAMED SRN
- CN-MF-000037456
- FDA FEI number
- 3012777736
- DUNS number
- 712452198
- EUDAMED status
- Active
- EUDAMED registered name
- EMSRUN GROUP
- Registered address
- 8-7 Huide Road,Huishan Area, 214000, Wuxi,Jiangsu, China
- leo@emsrun.com
- PRRC contact
- Weifeng Li
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 4 Aug 2029
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2502508-1 Active
Quality management system EU MDR
- Issued
- 5 Aug 2024
- Expires
- 4 Aug 2029
Frequently asked questions
How many devices does EMSRUN GROUP have in the registry?
The registry currently lists 173 devices for EMSRUN GROUP. Devices recorded under merged duplicate company entries are counted once.
Which registries list EMSRUN GROUP's devices?
Among its 50 most recently registered devices, EMSRUN GROUP has devices listed in EUDAMED (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EMSRUN GROUP's devices fall under?
Among its 50 most recently registered devices, the classes recorded for EMSRUN GROUP's devices are Class I. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for EMSRUN GROUP?
EUDAMED lists 1 certificate for EMSRUN GROUP (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 5 Aug 2024.
What are the newest devices from EMSRUN GROUP in the registry?
The most recently registered devices listed for EMSRUN GROUP include RESCUE RESSENTIALS REMZ0001, RESCUE RESSENTIALS CPREBD0014/Blue/7.5cm*4.5m, NORSE RESCUE B.A.D (Bandage Anchoring Device) and PrepEM Wild 18in splint.