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Eco
EUDAMEDClass I (EU MDR)
Ref BLUE NITRILE LModel EM0102Ref BLUE NITRILE XLRef BLUE NITRILE-SRef BLUE NITRILE M
Identity
- Trade Name
- ECO EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMEDBLUE NITRILE L EUDAMEDBLUE NITRILE XL EUDAMEDBLUE NITRILE-S EUDAMEDBLUE NITRILE M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265562225 EUDAMED06933265562232 EUDAMED06933265562201 EUDAMED06933265562218 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265562225 EUDAMED06933265562232 EUDAMED06933265562201 EUDAMED06933265562218 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Eco by Blue Sail Medical 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 | 69332655EM01021562864B | Class I | Active |
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Manufacturer
- Manufacturer
- Blue Sail Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001139
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED eb890bd6-ec40-4877-b13a-d6107746cc49 61 fields · synced Aug 3, 2026
- EUDAMED ba07328d-2ec8-49d9-9756-d2f9a2219f04 61 fields · synced May 16, 2026
- EUDAMED 0716487e-2eae-4756-9667-42f65b257f9a 61 fields · synced May 18, 2026
- EUDAMED 46156c37-656a-4087-82da-050d2f582421 61 fields · synced May 18, 2026