Identity
- Device Name
- Soft Dam EUDAMED
- Model / Reference
- Soft Dam EUDAMEDFP1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800032400241 EUDAMED
- Basic UDI-DI
- 88000324SDA4 EUDAMED
- Unit of Use DI
- 08800032401774 EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Soft Dam by Nexobio 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 | 88000324SDA4 | Class I | Active |
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Manufacturer
- Manufacturer
- Nexobio Co., Ltd.
- EUDAMED SRN
- KR-MF-000043543
- Authorised Representative
- MEGALİNE DENTAL İTH. İHR. SAN. TİC. LTD. ŞTİ. TR-AR-000046036
Sources (1)
- EUDAMED 2dc9e516-441d-462d-b74c-a7c46f078d73 61 fields · synced Jul 26, 2026