Identity
- Trade Name
- OPER TAPE 10 x 1000 cm EUDAMED
- Device Name
- Adhesive non-woven fabric EUDAMED
- Model / Reference
- 0032230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097878609 EUDAMED
- Basic UDI-DI
- 8428097TAPE99 EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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 TAPE 10 x 1000 cm by Iberhospitex, S.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8428097TAPE99 | Class I | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED 68f9e299-ef67-4a6c-9562-fc9dbdb833f9 61 fields · synced Jun 18, 2026