Identity
- Trade Name
- Heka Plast fix sensitive EUDAMED
- Device Name
- Tape EUDAMED
- Model / Reference
- PL0282 EUDAMEDPL0283 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886030387 EUDAMED08715886030400 EUDAMED
- Basic UDI-DI
- 8715886TapeME EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Heka Plast fix sensitive by Allion BV h.o.d.n. van Heek Medical — 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 | 8715886TapeME | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-MF-000003490
Sources (2)
- EUDAMED 2f5a122c-398a-45b2-9f51-b38aece1369a 61 fields · synced Oct 6, 2026
- EUDAMED eed3c858-958a-4f9f-b387-35c598be7178 61 fields · synced May 17, 2026