Identity
- Trade Name
- Universal Procedure Pack EUDAMED
- Device Name
- Universal Procedure Pack EUDAMED
- Model / Reference
- 220240 EUDAMED172101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327005294 EUDAMED16942327040042 EUDAMED16942327014647 EUDAMED
- Basic UDI-DI
- 694109407371FG EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Universal Procedure Pack by Winner Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 694109407371FG | Class I | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED d92ba964-f246-43e0-a948-d0e373ac269d 61 fields · synced Jul 29, 2026
- EUDAMED c1c0c6ff-0942-43b9-880b-a33b45465aec 61 fields · synced May 18, 2026
- EUDAMED 623f9ff1-b343-445a-91f3-b74127c99d8d 61 fields · synced May 19, 2026