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Royaldent Latex Examination Gloves (examination Gloves, Powder Free)
EUDAMEDClass I (EU MDR)
Ref RD 63868-LTX-PFModel LATEX EXAMINATION GLOVES POWDER FREE
Identity
- Trade Name
- ROYALDENT LATEX EXAMINATION GLOVES (EXAMINATION GLOVES, POWDER FREE) EUDAMED
- Device Name
- LATEX EXAMINATION GLOVES POWDER FREE EUDAMED
- Model / Reference
- LATEX EXAMINATION GLOVES POWDER FREE EUDAMEDRD 63868-LTX-PF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00723860638687 EUDAMED
- Basic UDI-DI
- 0723860471728V EUDAMED
- EMDN Code
- T010201 LATEX 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
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
Royaldent Latex Examination Gloves (examination Gloves, Powder Free) by Mexpo International, Inc. — Class I — MDR — listed in EUDAMED
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 | 0723860471728V | Class I | Active |
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Manufacturer
- Manufacturer
- Mexpo International, Inc.
- EUDAMED SRN
- US-MF-000032548
- Authorised Representative
- Blossom Europe, S.L. ES-AR-000019689
Sources (1)
- EUDAMED 38c6344c-6cc4-4ba9-a955-d8a6398a6616 61 fields · synced Jun 19, 2026