Identity
- Device Name
- Oversleeves EUDAMED
- Model / Reference
- 40202, 40104, 40104PP EUDAMED40202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973219629000 EUDAMED
- Basic UDI-DI
- 697321962109K4 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Oversleeves by Ammex-Weida (Hubei) Health and Safety Products 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 | 697321962109K4 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5a428c1a-89b9-44c2-b68f-2735381891ae 61 fields · synced Oct 6, 2026