Identity
- Trade Name
- DURASENSE EUDAMED
- Device Name
- Powder Free Natural Rubber Latex Sterile Surgical Gloves EUDAMED
- Model / Reference
- Durasense EUDAMEDNR-SG-127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08997030302001 EUDAMED
- Basic UDI-DI
- 899703030NRSGRV 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
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
Durasense by PT. Medisafe Technologies — 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 | 899703030NRSGRV | Class IIa | Active |
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Manufacturer
- Manufacturer
- PT. Medisafe Technologies
- EUDAMED SRN
- ID-MF-000017133
- Authorised Representative
- Theo Manufacturing B.V. NL-AR-000006691
Sources (1)
- EUDAMED 8b0fb827-de16-4d5f-8950-09c519e2d990 61 fields · synced Jul 9, 2026