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Farmadosis
EUDAMEDClass I (EU MDR)
Ref 02.1513100LBModel EM0102Ref 02.1513200MBRef 02.1513200SBRef 02.1513200LBRef 02.1513100XLB
Identity
- Trade Name
- Farmadosis EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMED02.1513100LB EUDAMED02.1513200MB EUDAMED02.1513200SB EUDAMED02.1513200LB EUDAMED02.1513100XLB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265500623 EUDAMED06933265561761 EUDAMED06933265561754 EUDAMED06933265561778 EUDAMED06933265500630 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265500623 EUDAMED06933265561761 EUDAMED06933265561754 EUDAMED06933265561778 EUDAMED06933265500630 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Farmadosis 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 (5)
- EUDAMED b9dae188-1a07-498e-9001-8e17453c3cfe 61 fields · synced Jul 24, 2026
- EUDAMED e37e6e3f-97db-425a-a050-ccfe423718b3 61 fields · synced May 17, 2026
- EUDAMED 57ca563f-4da9-4db2-938e-cd3b767ba326 61 fields · synced May 17, 2026
- EUDAMED fe2ba33b-dddd-4a02-a8ce-dec9dda5358b 61 fields · synced May 18, 2026
- EUDAMED 799867d5-5009-473e-8548-b7069dac8e8e 61 fields · synced May 18, 2026