Wandy Rubber Industrial Co., Ltd
Active in EUDAMEDTaiwanfrom SRN EUDAMED FDA SRN TW-MF-000013312 FEI 3003749270
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What Wandy Rubber Industrial Co., Ltd makes
Wandy Rubber Industrial Co., Ltd manufactures reusable and disposable self-adhesive electrodes, including ECG monitoring electrodes, neurostimulation electrodes, and conductive rubber pads designed for medical signal transmission and stimulation applications. Their product line also includes general-purpose self-adhesive electrodes for clinical and diagnostic use.
The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed database and the FDA’s 510(k) premarket notification system. The manufacturer is based in Taiwan.
Catalogue
Body Signal Ecg Electrode Ref K031174
Regimes: 510(k) Registry: 510(k)Wandy Self-Adhesive Neurostimulation Electrode Ref K002219
Regimes: CE MDR 510(k) Registry: 510(k)Wandy Silicon Conductive Rubber Pad Ref Q-01
Regimes: CE MDR 510(k) Registry: EUDAMEDWandy Self-adhesive Electrodes Ref P4S-50x50mm-T
Regimes: CE MDR Registry: EUDAMEDWandy Self-adhesive Electrodes Ref P4-50x50mm-T
Regimes: CE MDR 510(k) Registry: EUDAMED
Company details
- EUDAMED SRN
- TW-MF-000013312
- FDA FEI number
- 3003749270
- EUDAMED status
- Active
- EUDAMED registered name
- Wandy Rubber Industrial Co., Ltd
- EUDAMED abbreviated name
- Wandy
- Registered address
- No.48, Lane 392, Fu Teh 1 Rd, Xi Zhi Dist. 221, 221, New Taipei City, Taiwan
- Website
- www.wandy.com.tw
- [email protected]
- Phone
- +886 2 26943185
- PRRC contact
- Jack Yu
From the company website
Silicone Electrode Pads Manufacturer Taiwan-Wandy:「35 years of experience+Good reputation+Quality guarantee」.We provide self-adhesive electrode pads,electrosurgical circuit pads...etc.Please contact us.
Frequently asked questions
How many devices does Wandy Rubber Industrial Co., Ltd have in the registry?
The registry currently lists 5 devices for Wandy Rubber Industrial Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wandy Rubber Industrial Co., Ltd's devices?
Among its 5 most recently registered devices, Wandy Rubber Industrial Co., Ltd has devices listed in EUDAMED (3 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wandy Rubber Industrial Co., Ltd's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Wandy Rubber Industrial 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 Wandy Rubber Industrial Co., Ltd in the registry?
The most recently registered devices listed for Wandy Rubber Industrial Co., Ltd include BODY SIGNAL ECG ELECTRODE, WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE, Wandy Silicon Conductive Rubber Pad and Wandy Self-adhesive Electrodes.