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Comport
EUDAMEDClass IIa (EU MDR)
Ref C22R6013Model COMPORT, COMPORT C, COMPORT L, COMPORT T, COMPORT TN, COMPORT PLUS, COMPORT C PLUS, COMPORT L PLUS, COMPORT T PLUS, COMPORT TN PLUS, COMPORT D PLUS
by RET, Inc.
Identity
- Trade Name
- COMPORT EUDAMED
- Device Name
- Sterile single use IOL Placement System EUDAMED
- Model / Reference
- COMPORT, COMPORT C, COMPORT L, COMPORT T, COMPORT TN, COMPORT PLUS, COMPORT C PLUS, COMPORT L PLUS, COMPORT T PLUS, COMPORT TN PLUS, COMPORT D PLUS EUDAMEDC22R6013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809495410088 EUDAMED
- Basic UDI-DI
- 880949541TCF-MDRY2 EUDAMED
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Comport by RET, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880949541TCF-MDRY2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- RET, Inc.
- EUDAMED SRN
- KR-MF-000014159
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (1)
- EUDAMED d4f866d1-2bf9-4dfd-8c5e-31b1dcc3075f 61 fields · synced Jun 18, 2026