Identity
- Trade Name
- Punctal Dilator EUDAMED
- Device Name
- Reusable Ophthalmic Punctal Dilator EUDAMED
- Model / Reference
- RR9-S95-H1（TC-34015-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975044458206 EUDAMED
- Basic UDI-DI
- 697504445RPUNCTALDILATOVH EUDAMED
- EMDN Code
- L17010101 LACRIMAL DUCTS DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Punctal Dilator by Sihong Ophsurin Co., Ltd — Class I — 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 | 697504445RPUNCTALDILATOVH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sihong Ophsurin Co., Ltd.
- EUDAMED SRN
- CN-MF-000037458
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 1bce3d04-32b1-465d-bf15-76ab1da0d5fb 61 fields · synced Jul 8, 2026