Identity
- Trade Name
- WeeSpecs Supreme, Medium, 50/pk EUDAMED
- Device Name
- Jaundice Management EUDAMED
- Model / Reference
- 989805604161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850018561143 EUDAMED
- Basic UDI-DI
- 0850018561JAUNDICEMR EUDAMED
- Direct Marketing DI
- 00850018561143 EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Phototherapy eye protector, reusable
WeeSpecs Supreme, Medium, 50/pk by International Biomedical, Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850018561JAUNDICEMR | Class I | Active |
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Manufacturer
- Manufacturer
- International Biomedical
- EUDAMED SRN
- US-MF-000017330
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3ef5d3dc-268a-4869-a272-fb4aa48e6572 61 fields · synced Jun 19, 2026