Identity
- Trade Name
- OPER TAPE CLEAR 9,1 m x 7,5 cm EUDAMED
- Device Name
- Micro-perforated transparent PE plastic surgical tape with hypoallergenic acrylic adhesive EUDAMED
- Model / Reference
- 0037159 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08428097048101 EUDAMED
- Basic UDI-DI
- 8428097CLEARZF 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 CLEAR 9, 1 m x 7, 5 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 | 8428097CLEARZF | Class I | Active |
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Manufacturer
- Manufacturer
- Iberhospitex, S.A.
- EUDAMED SRN
- ES-MF-000000160
Sources (1)
- EUDAMED f7256212-3fc0-4ac1-af99-32f7e352682d 61 fields · synced Jul 14, 2026