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Naturflex Orto
EUDAMEDClass IIa (EU MDR)
Ref 129127Ref 129124Ref 129125Ref 129128Ref 129126
Identity
- Trade Name
- Naturflex Orto EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powder Free EUDAMED
- Model / Reference
- 129127 EUDAMED129124 EUDAMED129125 EUDAMED129128 EUDAMED129126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363505158 EUDAMED00806363505127 EUDAMED00806363505134 EUDAMED00806363505165 EUDAMED00806363505141 EUDAMED
- Basic UDI-DI
- 806363LSGFM4 EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Naturflex Orto by Kanam Latex Industries Private Limited — Class IIa — 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 | 806363LSGFM4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kanam Latex Industries Private Limited
- EUDAMED SRN
- IN-MF-000022741
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (5)
- EUDAMED a37fb547-2139-4a89-9abc-c847f784de79 61 fields · synced Oct 6, 2026
- EUDAMED 3f5867d8-b1a6-4edd-9cb8-0c98287544b0 61 fields · synced May 16, 2026
- EUDAMED de01ef2c-ba14-4c10-ab9b-97d8649d2c51 61 fields · synced May 17, 2026
- EUDAMED 7e4d4d49-3666-4a32-a76c-21e616287b6d 61 fields · synced May 18, 2026
- EUDAMED fdba2df5-5e15-464e-9374-49c2df1154d3 61 fields · synced May 19, 2026