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General Surgery Procedure Pack
EUDAMEDClass IIa (EU MDR)
Ref SYN-GEN02-001Model GEN 02
Identity
- Trade Name
- General Surgery Procedure Pack EUDAMED
- Device Name
- GEN (General Surgery) EUDAMED
- Model / Reference
- GEN 02 EUDAMEDSYN-GEN02-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065021834015 EUDAMED
- Basic UDI-DI
- 5065021834SYNPP001YZ EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Designed to support a variety of general surgical procedures by maintaining a sterile environment. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
General Surgery Procedure Pack by SYNDEO Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 5065021834SYNPP001YZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- SYNDEO Medical
- EUDAMED SRN
- BE-PR-000044136
Sources (1)
- EUDAMED 797dd16e-8ad5-44f9-b9b3-027cb1708e9a 61 fields · synced Jul 17, 2026