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Ophthalmic Reusable Pack
EUDAMEDClass IIa (EU MDR)
Ref FMSR200102Model FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204
Identity
- Trade Name
- Ophthalmic Reusable Pack EUDAMED
- Device Name
- Ophthalmic Reusable Pack EUDAMED
- Model / Reference
- FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204 EUDAMEDFMSR200102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464944067 EUDAMED
- Basic UDI-DI
- 697246494MD03100ORPM001YT EUDAMED
- EMDN Code
- Q020680 PHACOEMULSIFICATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Ophthalmic Reusable Pack by Innolcon Medical Technology (Suzhou) Co., Ltd. — 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 | 697246494MD03100ORPM001YT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innolcon Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012689
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED dd80f4fc-43c8-4eb5-aac9-273254e54dc2 61 fields · synced Jun 19, 2026