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santex powdered
EUDAMEDClass IIa (EU MDR)
Ref RC11050060_0016Ref RC11050075_0016Ref RC11050090_0016
Identity
- Trade Name
- santex powdered EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powdered EUDAMED
- Model / Reference
- RC11050060_0016 EUDAMEDRC11050075_0016 EUDAMEDRC11050090_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363501211 EUDAMED00806363501242 EUDAMED00806363501273 EUDAMED
- Basic UDI-DI
- 806363LSGPMQ EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
santex powdered 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 | 806363LSGPMQ | 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 (3)
- EUDAMED 5e40a46b-0bf6-44f2-9b72-31ec514b4472 61 fields · synced Oct 6, 2026
- EUDAMED 50dfc8ad-7b43-401e-a50c-5ca7dc82153b 61 fields · synced Jul 28, 2026
- EUDAMED a770c1ed-beb9-4bc1-95dd-c60245bb6466 61 fields · synced Jul 30, 2026