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iiSi
EUDAMEDClass I (EU MDR)
Ref Disposable nitrile glove, pink color, size XLModel EM0102
Identity
- Trade Name
- iiSi EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMEDDisposable nitrile glove, pink color, size XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265562546 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265562546 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
iiSi 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 (2)
- EUDAMED 3a8d16e3-7b21-4127-b57b-1eccc0f1c488 61 fields · synced Jun 18, 2026
- EUDAMED 3a8d16e3-7b21-4127-b57b-1eccc0f1c488-1 61 fields · synced Jun 10, 2026