Elastomade Accessories Sdn Bhd
Active in EUDAMEDMalaysiafrom SRN EUDAMED FDA SRN MY-MF-000024531 FEI 3005822857
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Elastomade Accessories Sdn Bhd makes
Elastomade Accessories Sdn Bhd manufactures dental rubber dams and related accessories, including standard rubber dams with or without frames, as well as non-sterile powder-free variants designed for isolation during dental procedures.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the US.
Catalogue
Royal Shield Powder Free Latex Dental Dam Ref L-DD-55-BG-T-BL
Regimes: CE MDR Registry: EUDAMEDRoyal Shield Rubber Dams Ref K942992
Regimes: 510(k) Registry: 510(k)Standard Rubber Dam With Or Without Frames Ref K905470
Regimes: 510(k) Registry: 510(k)Royal Shield Non-Sterile Powder-Free Rubber Dams Ref K952628
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- MY-MF-000024531
- FDA FEI number
- 3005822857
- EUDAMED status
- Active
- EUDAMED registered name
- Elastomade Accessories Sdn Bhd
- EUDAMED abbreviated name
- EASB
- Registered address
- Perusahaan Selat Klang Utara,, Lot 7, Lengkungan Hishamuddin,, 42000, Port Klang, Selangor, Malaysia
- Website
- www.elastomade.com/
- [email protected]
- Phone
- +60356342982
- PRRC contact
- Karen Ooi
Frequently asked questions
How many devices does Elastomade Accessories Sdn Bhd have in the registry?
The registry currently lists 4 devices for Elastomade Accessories Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elastomade Accessories Sdn Bhd's devices?
Among its 4 most recently registered devices, Elastomade Accessories Sdn Bhd has devices listed in EUDAMED (1 device) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Elastomade Accessories Sdn Bhd's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Elastomade Accessories Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Elastomade Accessories Sdn Bhd in the registry?
The most recently registered devices listed for Elastomade Accessories Sdn Bhd include Royal Shield Powder Free Latex Dental Dam, ROYAL SHIELD RUBBER DAMS, STANDARD RUBBER DAM WITH OR WITHOUT FRAMES and ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS.