Identity
- Trade Name
- Surgitrac EUDAMED
- Device Name
- Punctal dilator and lacrimal probe double ended EUDAMED
- Model / Reference
- PD07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976939131754 EUDAMED
- Basic UDI-DI
- B-06976939131754 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
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Also classified as Lacrimal dilator, reusable.
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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-06976939131754 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sihong Surgitrac Co., Ltd
- EUDAMED SRN
- CN-MF-000041149
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ed0321d2-1476-4ee8-83bf-357a6ea5ac0e 61 fields · synced Jul 24, 2026