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Ophthalmic Singleuse Pack-FMS-Singleuse
EUDAMEDClass IIa (EU MDR)
Ref FMSC200104Model FMSC100001,FMSC200001, FMSC300001, FMSC100101-FMSC100104, FMSC100201-FMSC100204, FMSC200101-FMSC200104, FMSC200201-FMSC200204, FMSC300101-FMSC300104, FMSC30020-FMSC300204Ref FMSC100304Model FMSC100301, FMSC100302, FMSC100303, FMSC100304, FMSC200301, FMSC200302, FMSC200303, FMSC200304, FMSC300301, FMSC300302, FMSC300303, FMSC300304Ref FMSC200201Ref FMSC300203Ref FMSC100102Ref FMSC200204Ref FMSC100101Ref FMSC300302Ref FMSC300202Ref FMSC200304Ref FMSC100103Ref FMSC300304Ref FMSC300303Ref FMSC100303Ref FMSC300103Ref FMSC300301Ref FMSC200303Ref FMSC300204Ref FMSC100001Ref FMSC100301Ref FMSC300104Ref FMSC200103Ref FMSC100104Ref FMSC100201Ref FMSC200302Ref FMSC100203
Identity
- Trade Name
- Ophthalmic Singleuse Pack-FMS-Singleuse EUDAMED
- Device Name
- Ophthalmic Singleuse Pack-FMS-Singleuse EUDAMED
- Model / Reference
- FMSC100001,FMSC200001, FMSC300001, FMSC100101-FMSC100104, FMSC100201-FMSC100204, FMSC200101-FMSC200104, FMSC200201-FMSC200204, FMSC300101-FMSC300104, FMSC30020-FMSC300204 EUDAMEDFMSC200104 EUDAMEDFMSC100301, FMSC100302, FMSC100303, FMSC100304, FMSC200301, FMSC200302, FMSC200303, FMSC200304, FMSC300301, FMSC300302, FMSC300303, FMSC300304 EUDAMEDFMSC100304 EUDAMEDFMSC200201 EUDAMEDFMSC300203 EUDAMEDFMSC100102 EUDAMEDFMSC200204 EUDAMEDFMSC100101 EUDAMEDFMSC300302 EUDAMEDFMSC300202 EUDAMEDFMSC200304 EUDAMEDFMSC100103 EUDAMEDFMSC300304 EUDAMEDFMSC300303 EUDAMEDFMSC100303 EUDAMEDFMSC300103 EUDAMEDFMSC300301 EUDAMEDFMSC200303 EUDAMEDFMSC300204 EUDAMEDFMSC100001 EUDAMEDFMSC100301 EUDAMEDFMSC300104 EUDAMEDFMSC200103 EUDAMEDFMSC100104 EUDAMEDFMSC100201 EUDAMEDFMSC200302 EUDAMEDFMSC100203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464943091 EUDAMED06972464942889 EUDAMED06972464943121 EUDAMED06972464943473 EUDAMED06972464942742 EUDAMED06972464943152 EUDAMED06972464942735 EUDAMED06972464943527 EUDAMED06972464943466 EUDAMED06972464943213 EUDAMED06972464942759 EUDAMED06972464943541 EUDAMED06972464943534 EUDAMED06972464942872 EUDAMED06972464943411 EUDAMED06972464943510 EUDAMED06972464943206 EUDAMED06972464943480 EUDAMED06972464942728 EUDAMED06972464942858 EUDAMED06972464943428 EUDAMED06972464943084 EUDAMED06972464942766 EUDAMED06972464942797 EUDAMED06972464943190 EUDAMED06972464942810 EUDAMED
- Basic UDI-DI
- 697246494MD03100FSM001XF EUDAMED697246494MD03100FSP001Y4 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
No
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 Singleuse Pack-FMS-Singleuse 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 | 697246494MD03100FSM001XF | 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 (26)
- EUDAMED 0f79d935-5187-458a-8c3f-af8383fdc0be 61 fields · synced Oct 6, 2026
- EUDAMED f88a0791-bea5-41f5-8969-aedd236a1588 61 fields · synced May 16, 2026
- EUDAMED 223f7f8b-7c2d-4ba4-a240-81533aa6386d 61 fields · synced May 17, 2026
- EUDAMED 08e3ebb6-42f1-4d1c-8167-519afb088f41 61 fields · synced May 17, 2026
- EUDAMED e50b8b3d-f781-4476-bf0f-561856fff8ec 61 fields · synced May 17, 2026
- EUDAMED 64e8547d-a63f-420a-b678-a795655ad1dd 61 fields · synced May 17, 2026
- EUDAMED e06b6795-ec28-48a9-aa57-ef7917aecafc 61 fields · synced May 17, 2026
- EUDAMED 92065945-f2f6-4d90-a41d-dfb01128f983 61 fields · synced May 17, 2026
- EUDAMED d3bcd498-55a4-4b90-8bfa-bed534057fad 61 fields · synced May 17, 2026
- EUDAMED 08e389dd-bdf5-4b84-9191-76ce276ebffa 61 fields · synced May 17, 2026
- EUDAMED ce8cd2a7-a0d6-478e-a2ad-f27fb81ca2f4 61 fields · synced May 17, 2026
- EUDAMED 7ef8c925-6faa-4788-84bd-e40d3117f470 61 fields · synced May 17, 2026
- EUDAMED 64dccbe3-33f8-44c0-86cc-b748058b979d 61 fields · synced May 17, 2026
- EUDAMED 60299a8a-9a6e-43c4-a6c9-f99ea3628099 61 fields · synced May 17, 2026
- EUDAMED c5ab9e3b-8cd7-4d11-afd8-7d7756c54ff6 61 fields · synced May 17, 2026
- EUDAMED f3656418-8416-4019-916e-51bb0f1cf2da 61 fields · synced May 18, 2026
- EUDAMED fc2c6c2d-c116-4c2c-a403-3a0723647b59 61 fields · synced May 18, 2026
- EUDAMED 0cd58108-4b8b-4059-aa0a-8963c6db8c3d 61 fields · synced May 18, 2026
- EUDAMED 9778460a-55c4-4283-b97d-6fcb6d731f6b 61 fields · synced May 18, 2026
- EUDAMED 9a8c47df-cfd7-4f1a-afd6-54634539936c 61 fields · synced May 18, 2026
- EUDAMED 84901d67-9cfe-4c18-a4dd-3eda340afa22 61 fields · synced May 18, 2026
- EUDAMED bf41893e-0de2-460e-a09b-2c8a40de2da1 61 fields · synced May 18, 2026
- EUDAMED 52eab479-3f1a-4735-a1c9-bb9703270bb4 61 fields · synced May 18, 2026
- EUDAMED 9c8581a6-369c-4ce0-afd8-adf8f0619de3 61 fields · synced May 18, 2026
- EUDAMED fa504d03-c085-4d1f-886b-0d3909805527 61 fields · synced May 18, 2026
- EUDAMED cc3e5410-b6b0-4528-b10c-f16240436287 61 fields · synced May 19, 2026