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Wax Disk
EUDAMEDClass IIa (EU MDR)
Ref Shade：Green, Spec:98*40mm, Net Weight:262gModel Single Layer; Multi-Layer
Identity
- Trade Name
- Wax Disk EUDAMED
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Single Layer; Multi-Layer EUDAMEDShade：Green, Spec:98*40mm, Net Weight:262g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942555814111 EUDAMED
- Basic UDI-DI
- 6975187612aSZKQG EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Wax Disk is a medical device designed for the treatment of glaucoma, featuring a single-layer and multi-layer PMMA block with an 8mm diameter and a net weight of 262g. This device provides precise measurement and monitoring of intraocular pressure (IOP) in patients undergoing trabeculectomy surgery.
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 | 6975187612aSZKQG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huliang(Shanghai)Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013327
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (1)
- EUDAMED 79e2f9c7-9264-4868-b61c-e3236dc91387-1 61 fields · synced Jul 27, 2026