Identity
- Trade Name
- HEKA SOFT EUDAMED
- Device Name
- EYE PAD EUDAMED
- Model / Reference
- VA0913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975662250121 EUDAMED
- Basic UDI-DI
- 697566225EYEPADVT EUDAMED
- Direct Marketing DI
- 06975662250121 EUDAMED
- EMDN Code
- M040301 EYE PADS, COTTON OR NON-WOVEN MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Heka Soft by Suzhou Vicon Industrial CO., LTD. — 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 | 697566225EYEPADVT | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Vicon Industrial CO., LTD.
- EUDAMED SRN
- CN-MF-000028246
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8c85c4d2-24c7-454e-9a07-6e30c7d7cc98 61 fields · synced Jul 17, 2026