Dk Jellia Skin 1001
Model Natural rubber latex male condoms (non-medicated)
Active
CE MDR
Valid until
23 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8938503458DKVNTF01LH 08938503458009 | Date8 May 2026 | StatusActive |
Certificates
- KR25/00000120 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 23 Oct 2025
- Expires
- 23 Oct 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Natural rubber latex male condoms (non-medicated)
- Primary DI / UDI-DI
- 08938503458009
- Basic UDI-DI
- 8938503458DKVNTF01LH
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- VN-MF-000043647
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Dongkuk Vietnam Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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