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Phaco Handpiece
EUDAMEDClass IIb (EU MDR)
Ref HP041Model HP021, HP041,HP041MRef HP041M
Identity
- Trade Name
- Phaco Handpiece EUDAMED
- Device Name
- Phaco Handpiece EUDAMED
- Model / Reference
- HP021, HP041,HP041M EUDAMEDHP041 EUDAMEDHP041M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972464942063 EUDAMED06972464942070 EUDAMED
- Basic UDI-DI
- 697246494MD03100PH0016E EUDAMED
- EMDN Code
- Q020680 PHACOEMULSIFICATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Phaco Handpiece by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIb — 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 | 697246494MD03100PH0016E | 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 (2)
- EUDAMED 9d6dce7a-5acf-4a1a-9373-59915988240a 61 fields · synced Oct 6, 2026
- EUDAMED 160acc13-2aac-4a76-997d-0a8c867c726a 61 fields · synced May 18, 2026