Identity
- Trade Name
- OPER CAT POUCH 16x5CM EUDAMEDOPER CAT POUCH 16 X 5 CM EUDAMED
- Device Name
- Catheters self-adhesive pouch EUDAMED
- Model / Reference
- 0037449 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097939300 EUDAMED
- Basic UDI-DI
- B-08428097939300 EUDAMED8428097CATP6L EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMEDM04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
OPER CAT POUCH 16x5CM by Iberhospitex, S.A. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08428097939300 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08428097939300 | Class I | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (2)
- EUDAMED 429c165b-ac15-4e8a-bc06-6aab6371259e 61 fields · synced Jul 22, 2026
- EUDAMED b8363868-04eb-4ba6-ae4c-68f63d11c379 61 fields · synced May 19, 2026