Identity
- Device Name
- SLEEVE EUDAMED
- Model / Reference
- SLEEVE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800075213174 EUDAMED
- Basic UDI-DI
- B-08800075213174 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Sleeve by I Do Biotech Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800075213174 | Class IIb | Active |
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Manufacturer
- Manufacturer
- I Do Biotech Co., Ltd
- EUDAMED SRN
- KR-MF-000022539
- Authorised Representative
- Valdent S.L. ES-AR-000022075
Sources (1)
- EUDAMED f0d38f7b-0e1c-4605-bda2-65bd4e5469e3 61 fields · synced Aug 2, 2026