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Ophthalmic Singleuse Pack-Phaco Tip Kit
EUDAMEDClass IIa (EU MDR)
Ref TSC300304Model TSC300301, TSC300302, TSC300303, TSC300304Ref TSC300302Ref TSC300301Ref TSC100104Model TSC100101, TSC100102, TSC100103, TSC100104, TSC200201, TSC200202, TSC200203, TSC200204Ref TSC100101Ref TSC200204
Identity
- Trade Name
- Ophthalmic Singleuse Pack-Phaco Tip Kit EUDAMED
- Device Name
- Ophthalmic Singleuse Pack-Phaco Tip Kit EUDAMED
- Model / Reference
- TSC300301, TSC300302, TSC300303, TSC300304 EUDAMEDTSC300304 EUDAMEDTSC300302 EUDAMEDTSC300301 EUDAMEDTSC100101, TSC100102, TSC100103, TSC100104, TSC200201, TSC200202, TSC200203, TSC200204 EUDAMEDTSC100104 EUDAMEDTSC100101 EUDAMEDTSC200204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464942469 EUDAMED06972464942445 EUDAMED06972464942438 EUDAMED06972464942346 EUDAMED06972464942315 EUDAMED06972464942407 EUDAMED
- Basic UDI-DI
- 697246494MD03100PTKP001Z4 EUDAMED697246494MD03100PTKM001YF 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
EUDAMEDEUDAMED
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-Phaco Tip Kit 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 | 697246494MD03100PTKP001Z4 | 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 (6)
- EUDAMED b2bdd9ea-a298-4ebd-97b3-f9114dcdac32 61 fields · synced Oct 6, 2026
- EUDAMED 69fbf382-47a4-4792-87a7-336e6bce0a99 61 fields · synced May 16, 2026
- EUDAMED 83cc121b-bfd9-455a-9cc6-23d239c64c4f 61 fields · synced May 17, 2026
- EUDAMED b7f43de0-f642-4feb-a590-d29f33541a94 61 fields · synced May 17, 2026
- EUDAMED 47e81bd8-656e-4f73-b861-0fcca8e3df46 61 fields · synced May 18, 2026
- EUDAMED d87d7723-ae27-4e23-b96e-76ac7a2beb0e 61 fields · synced May 19, 2026