Frame
by Guangzhou ZOHO Glasses Co., Ltd EUDAMED
Active
Ref RT-0049Model 3061,3062,3063,3064,3065,3066,3067,3068,3069,3070,3071,3072,3073, 3074,3075,3076,3078,3080,3081,3082,3083,G2312,G2313,G2314,G2315,G2301,G2304,G2303,G2302,7009,7008,7006,7005,7004,F15,F2,F13,F21,F20,F16,CP201.CP202,CP141,CP203,F9,F6,S1015,etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697383305Frame3Q | Date7 Feb 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Frame
- Model / Reference
- 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3073, 3074, 3075, 3076, 3078, 3080, 3081, 3082, 3083, G2312, G2313, G2314, G2315, G2301, G2304, G2303, G2302, 7009, 7008, 7006, 7005, 7004, F15, F2, F13, F21, F20, F16, CP201.CP202, CP141, CP203, F9, F6, S1015, etc, RT-0049
- Primary DI / UDI-DI
- 06973833053502
- Basic UDI-DI
- 697383305Frame3Q
- EMDN Code
- Q02100203 Metal and plastic spectacle frames without lenses
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000039885
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guangzhou ZOHO Glasses Co., Ltd
Properties
Other properties (13)
- 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