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Ophthalmic Singleuse Pack-I/A Handpiece Kit
EUDAMEDClass IIa (EU MDR)
Ref IHP011101Model IHP011101, IHP011102, IHP011103, IHP012101, IHP012102, IHP012103
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 EUDAMEDIHP011101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464944715 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 (1)
- EUDAMED bdb0f708-703d-4303-aab6-76e9e66ede10 61 fields · synced Jun 19, 2026