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Phacoemulsification Surgical Equipment-Generator
EUDAMEDClass IIb (EU MDR)
Ref YPE120Model YPE100, YPE200Ref FSW12Ref YPE110Ref FSW11
Identity
- Trade Name
- Phacoemulsification Surgical Equipment-Generator EUDAMEDPhacoemulsification Surgical Equipment-Footswitch EUDAMEDPhacoemulsification Surgical Equipment -Generator EUDAMED
- Device Name
- Phacoemulsification Surgical Equipment EUDAMED
- Model / Reference
- YPE100, YPE200 EUDAMEDYPE120 EUDAMEDFSW12 EUDAMEDYPE110 EUDAMEDFSW11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464942025 EUDAMED06972464942179 EUDAMED06972464942018 EUDAMED06972464942162 EUDAMED
- Basic UDI-DI
- 697246494MD03100PSS0014W EUDAMED
- Direct Marketing DI
- 06972464942025 EUDAMED06972464942179 EUDAMED06972464942018 EUDAMED06972464942162 EUDAMED
- EMDN Code
- Q020601 PHACOEMULSIFICATION SETS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Phacoemulsification Surgical Equipment-Generator by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED
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 | 697246494MD03100PSS0014W | Class IIb | 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 (4)
- EUDAMED 5d0adc32-cf0b-4743-86f1-423e9e61f0d8 61 fields · synced Jul 25, 2026
- EUDAMED df505a12-d903-4d14-8075-127acf8f2089 61 fields · synced May 16, 2026
- EUDAMED 4bf98534-2e12-4b16-baa1-13032ded2a05 61 fields · synced May 18, 2026
- EUDAMED 6299b615-4bda-45f8-b1a9-85cb937f886b 61 fields · synced May 18, 2026