Identity
- Trade Name
- EU-921 EUDAMED
- Device Name
- EU-921 EUDAMED
- Model / Reference
- EU-921 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04983087010888 EUDAMED
- Basic UDI-DI
- B-04983087010888 EUDAMED
- EMDN Code
- Z120601,Z120610 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
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
Eu-921 by Ito Co., Ltd. — Class IIa — 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-04983087010888 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ito Co., Ltd.
- EUDAMED SRN
- JP-MF-000021681
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4aaa88f5-1c03-4c4c-a042-5a2ab9677277 61 fields · synced Jul 19, 2026