Identity
- Trade Name
- Catheter Pack EUDAMED
- Device Name
- Procedure Pack EUDAMED
- Model / Reference
- 061PC04002A EUDAMED061PC01009CC2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240406118 EUDAMED09555240403926 EUDAMED
- Basic UDI-DI
- 955524040PP1SH3 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Catheter Pack by Itl Asia Pacific Sdn. Bhd. — 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 | 955524040PP1SH3 | Class I | Active |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fe7835de-f6c5-4cc0-865f-656978ffa5d5 61 fields · synced Jul 21, 2026
- EUDAMED d1a5e37e-4ed1-4c31-b93f-8c26dcfb8114 61 fields · synced May 19, 2026