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comfort powdered
EUDAMEDClass IIa (EU MDR)
Ref RC11072055_0016Ref RC11072065_0016Ref RC11072085_0016Ref RC11072060_0016Ref RC11072090_0016
Identity
- Trade Name
- comfort powdered EUDAMEDcomfort powdeered EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powdered EUDAMED
- Model / Reference
- RC11072055_0016 EUDAMEDRC11072065_0016 EUDAMEDRC11072085_0016 EUDAMEDRC11072060_0016 EUDAMEDRC11072090_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363503918 EUDAMED00806363503932 EUDAMED00806363503970 EUDAMED00806363503925 EUDAMED00806363503987 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
comfort 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 (5)
- EUDAMED d5656400-7c5a-464a-92d1-1656416ee794 61 fields · synced Oct 6, 2026
- EUDAMED 611afd58-c13c-4c39-8491-5b8ad4909d55 61 fields · synced Jun 20, 2026
- EUDAMED 9ae72796-371c-4cc9-b59a-3b18c4cbcbf1 61 fields · synced Jul 11, 2026
- EUDAMED 6254ecde-e71e-4f13-afa8-31b87c656388 61 fields · synced Jul 17, 2026
- EUDAMED 32ad874d-89b5-4c99-9c80-1a0c2ebc83aa 61 fields · synced Jul 18, 2026