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Ophthalmic Reusable Pack
EUDAMEDClass IIa (EU MDR)
Ref FMSR100301Model FMSR100301, FMSR100302, FMSR100303, FMSR100304, FMSR200301, FMSR200302, FMSR200303, FMSR200304, FMSR300301, FMSR300302, FMSR300303、FMSR300304Ref FMSR300102Model FMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204Ref FMSR300301Ref FMSR100302Ref FMSR100202Ref FMSR300302Ref FMSR100304Ref FMSR200104Ref FMSR100203Ref FMSR300202Ref FMSR100104Ref FMSR300104Ref FMSR200302Ref FMSR100201Ref FMSR100103Ref FMSR200101Ref FMSR300103Ref FMSR300001Ref FMSR200303Ref FMSR300101Ref FMSR200203Ref FMSR300204Ref FMSR200202Ref FMSR300201Ref FMSR200001Ref FMSR100102
Identity
- Trade Name
- Ophthalmic Reusable Pack EUDAMED
- Device Name
- Ophthalmic Reusable Pack EUDAMED
- Model / Reference
- FMSR100301, FMSR100302, FMSR100303, FMSR100304, FMSR200301, FMSR200302, FMSR200303, FMSR200304, FMSR300301, FMSR300302, FMSR300303、FMSR300304 EUDAMEDFMSR100301 EUDAMEDFMSR100001, FMSR200001, FMSR300001, FMSR100101-FMSR100104, FMSR100201-FMSR100204, FMSR200101-FMSR200104, FMSR200201-FMSR200204, FMSR300101-FMSR300104, FMSR300201-FMSR300204 EUDAMEDFMSR300102 EUDAMEDFMSR300301 EUDAMEDFMSR100302 EUDAMEDFMSR100202 EUDAMEDFMSR300302 EUDAMEDFMSR100304 EUDAMEDFMSR200104 EUDAMEDFMSR100203 EUDAMEDFMSR300202 EUDAMEDFMSR100104 EUDAMEDFMSR300104 EUDAMEDFMSR200302 EUDAMEDFMSR100201 EUDAMEDFMSR100103 EUDAMEDFMSR200101 EUDAMEDFMSR300103 EUDAMEDFMSR300001 EUDAMEDFMSR200303 EUDAMEDFMSR300101 EUDAMEDFMSR200203 EUDAMEDFMSR300204 EUDAMEDFMSR200202 EUDAMEDFMSR300201 EUDAMEDFMSR200001 EUDAMEDFMSR100102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464943848 EUDAMED06972464944395 EUDAMED06972464944500 EUDAMED06972464943855 EUDAMED06972464943794 EUDAMED06972464944517 EUDAMED06972464943879 EUDAMED06972464944081 EUDAMED06972464943800 EUDAMED06972464944456 EUDAMED06972464943756 EUDAMED06972464944418 EUDAMED06972464944180 EUDAMED06972464943787 EUDAMED06972464943749 EUDAMED06972464944050 EUDAMED06972464944401 EUDAMED06972464944371 EUDAMED06972464944197 EUDAMED06972464944388 EUDAMED06972464944135 EUDAMED06972464944470 EUDAMED06972464944128 EUDAMED06972464944449 EUDAMED06972464944043 EUDAMED06972464943732 EUDAMED
- Basic UDI-DI
- 697246494MD03100ORPP001ZG EUDAMED697246494MD03100ORPM001YT 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 | 697246494MD03100ORPP001ZG | 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 56fef552-e499-4138-99df-4ba7118f2fa1 61 fields · synced Oct 5, 2026
- EUDAMED 260f6374-be92-49e6-ac25-eed7ee72cfea 61 fields · synced May 16, 2026
- EUDAMED e8cdce75-2076-4dd7-a51b-e0a6807b1d6e 61 fields · synced May 16, 2026
- EUDAMED fb9141e8-a53c-4bd6-bc56-19f34409479a 61 fields · synced May 16, 2026
- EUDAMED 1dfc61a7-eca1-406a-aaf5-d4d392126b4c 61 fields · synced May 17, 2026
- EUDAMED 297ab1a1-fab5-4fe8-9e17-c33da6a47459 61 fields · synced May 17, 2026
- EUDAMED 1dca97d6-a3bb-4476-99cf-6ac71219e660 61 fields · synced May 17, 2026
- EUDAMED fade27b7-3354-4c16-b298-5c969074ead3 61 fields · synced May 17, 2026
- EUDAMED 411bb1c7-ea38-46e1-81ec-05b665b2c19e 61 fields · synced May 17, 2026
- EUDAMED ab25e83d-d0c7-4784-8a4f-1bc4a193d846 61 fields · synced May 17, 2026
- EUDAMED b14e95f0-ad13-4bcb-9c0d-c349b2c06dd3 61 fields · synced May 18, 2026
- EUDAMED 9ce1d829-3f05-4f00-90a6-52940939138b 61 fields · synced May 18, 2026
- EUDAMED 4972d1be-8f0a-4258-9824-abf6a0d99c86 61 fields · synced May 18, 2026
- EUDAMED b1a3af9b-6473-46d5-9428-25cd600049dc 61 fields · synced May 18, 2026
- EUDAMED 57ea2326-0b5b-4fe1-ba2d-18b514752234 61 fields · synced May 18, 2026
- EUDAMED 14fda504-af50-4e2d-9563-603f284d348c 61 fields · synced May 18, 2026
- EUDAMED 3ff88b38-c513-4bb7-96b0-0dde8e86ed81 61 fields · synced May 18, 2026
- EUDAMED bf838fa7-8ea7-4048-ab9b-fce6aec4f099 61 fields · synced May 18, 2026
- EUDAMED a69c2cfb-a018-4330-b59c-cd7d35e2008a 61 fields · synced May 18, 2026
- EUDAMED 0e807c5e-6a5a-42e8-a4fa-ecfd354b4477 61 fields · synced May 18, 2026
- EUDAMED 19e7e98c-ac24-4bcb-91db-0b578bf5969c 61 fields · synced May 18, 2026
- EUDAMED 56b0b0e4-234a-413e-838f-5e0d4404b6f1 61 fields · synced May 18, 2026
- EUDAMED 1c1f6240-9ce3-4a80-b447-128706b5b62f 61 fields · synced May 18, 2026
- EUDAMED ac008999-f346-41cf-9e56-d1cea7165c90 61 fields · synced May 18, 2026
- EUDAMED 4b21be6f-508d-4691-9e66-f129c4d2f394 61 fields · synced May 19, 2026
- EUDAMED 1f4b9604-51d7-402e-9f26-7e8fe499c1b9 61 fields · synced May 19, 2026