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1.5mm Orbital Floor Plate, 28.6*37.6mm, Thickness 0.6mm
EUDAMEDClass IIb (EU MDR)
Ref 221109030601Model Double-Y shape bone plate
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- 1.5mm Orbital Floor Plate, 28.6*37.6mm, Thickness 0.6mm EUDAMED
- Model / Reference
- Double-Y shape bone plate EUDAMED221109030601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292617919 EUDAMED
- Basic UDI-DI
- B-06950292617919 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
1.5mm Orbital Floor Plate, 28.6*37.6mm, Thickness 0.6mm by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06950292617919 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000017319
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a8b24d52-b02a-42c4-b66b-a29a2e77b538 61 fields · synced Oct 6, 2026