Ophthalmic Pack sterile
by Cobes Industries (Bago) Company Limited
Ref 55.5000Model SP5B Ophthalmology Surgical Pack
Active
CE MDR
Valid until
13 Jun 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number883000024GA0002KY 08830000246229 | Date19 Oct 2026 | StatusActive |
Certificates
- HK25/00000114 Active
Quality assurance EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 13 Jun 2025
- Expires
- 13 Jun 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ophthalmology Surgical Pack
- Model / Reference
- SP5B Ophthalmology Surgical Pack, 55.5000
- Primary DI / UDI-DI
- 08830000246229
- Basic UDI-DI
- 883000024GA0002KY
- EMDN Code
- T0202 Surgical procedural kits (excluding surgical instrument kits)
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- MM-MF-000012366
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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Properties
Other properties (12)
- 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