Identity
- Trade Name
- Surgitrac EUDAMED
- Device Name
- Cannula/PunctalDilators EUDAMED
- Model / Reference
- PD02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976939131600 EUDAMED
- Basic UDI-DI
- B-06976939131600 EUDAMED
- EMDN Code
- Q020701 LACRIMAL DUCT DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Lacrimal dilator, reusable
Surgitrac by Sihong Surgitrac Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal dilator, reusable.
- V. Mueller — STERIS CORPORATION · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06976939131600 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sihong Surgitrac Co., Ltd
- EUDAMED SRN
- CN-MF-000041149
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 46886934-60df-4200-8e85-6f1b26cb6446 61 fields · synced Jun 18, 2026