Aurelia Sonic
by Maxter Glove Manufacturing Sdn Bhd EUDAMEDGUDID
Active
Ref XS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number09555002105563 | Date8 Feb 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number955500211638CT | Date8 Dec 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Model / Reference
- XS EUDAMED93775 GUDID
- Primary DI / UDI-DI
- 09555002105563
- Basic UDI-DI
- 955500211638CT
- FDA Product Code
- LZA
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
- Device Class
- Class I
- Regulation Number
- 880.6250
- Market of Registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | XS | 93775 |
Manufacturer details
- EUDAMED SRN
- MY-MF-000016719
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Maxter Glove Manufacturing Sdn Bhd
Properties
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No