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Ophthalmic Singleuse Pack-I/A Handpiece Kit
EUDAMEDClass IIa (EU MDR)
Ref IHP012101Model IHP011101, IHP011102, IHP011103, IHP012101, IHP012102, IHP012103Ref IHP012102Ref IHP012103Ref IHP011102Ref IHP011103
Identity
- Trade Name
- Ophthalmic Singleuse Pack-I/A Handpiece Kit EUDAMED
- Device Name
- Ophthalmic Singleuse Pack-I/A Handpiece Kit EUDAMED
- Model / Reference
- IHP011101, IHP011102, IHP011103, IHP012101, IHP012102, IHP012103 EUDAMEDIHP012101 EUDAMEDIHP012102 EUDAMEDIHP012103 EUDAMEDIHP011102 EUDAMEDIHP011103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464944753 EUDAMED06972464944760 EUDAMED06972464944777 EUDAMED06972464944722 EUDAMED06972464944739 EUDAMED
- Basic UDI-DI
- 697246494MD03100IHK001UF 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
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
Ophthalmic Singleuse Pack-I/A Handpiece Kit by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIa — 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 | 697246494MD03100IHK001UF | 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 (5)
- EUDAMED a34e919b-b768-4966-bd11-8038dddbee3a 61 fields · synced Jul 26, 2026
- EUDAMED bc49b785-b187-4211-bc9d-59face1ae5f6 61 fields · synced May 17, 2026
- EUDAMED 5578d113-49bf-4980-97c0-58297e84ca96 61 fields · synced May 18, 2026
- EUDAMED e1a12857-87af-4349-bd4b-794d3b6ef9fb 61 fields · synced May 18, 2026
- EUDAMED 5c1cbecd-c1b6-48a5-8868-0284839e1130 61 fields · synced May 18, 2026