Identity
- Trade Name
- reading glasses EUDAMED
- Device Name
- Reading glasses Karin Mixed colors +1.5 RPC EUDAMED
- Model / Reference
- 862011670101 EUDAMED862011680102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941348142257 EUDAMED
- Basic UDI-DI
- 69413481ZPL5X EUDAMED
- EMDN Code
- Q0210010102 MULTIFOCAL ORGANIC OPHTHALMIC LENSES (BIFOCAL, TRIFOCAL) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
reading glasses by Wenzhou Zhantai Glasses 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 | 69413481ZPL5X | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Zhantai Glasses Co., Ltd
- EUDAMED SRN
- CN-MF-000040817
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 94082e69-814d-4c9b-ba12-e17b8e0d008d 61 fields · synced Jun 18, 2026