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evercare® SUPRA HP OP-gown M
EUDAMEDClass I (EU MDR)
Ref 259161Ref 259231Ref 259221
Identity
- Trade Name
- evercare® SUPRA HP OP-gown M EUDAMEDevercare® SUPRA HP OP-gown M, with hand towels EUDAMEDevercare® SUPRA HP OP-gown M-short, with hand towels EUDAMED
- Device Name
- OP Gowns, sterile EUDAMED
- Model / Reference
- 259161 EUDAMED259231 EUDAMED259221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129125214 EUDAMED06438129125283 EUDAMED06438129125276 EUDAMED
- Basic UDI-DI
- 6438129B0034HB EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
evercare® SUPRA HP OP-gown M by OneMed Group Oy — Class I — 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 | 6438129B0034HB | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (3)
- EUDAMED 87a921eb-9787-46ac-b386-7234e12d83ec 61 fields · synced Jul 10, 2026
- EUDAMED 4eda7f1c-627a-405b-9a7f-3efb8630ab36 61 fields · synced May 16, 2026
- EUDAMED 8d1c1277-8283-4975-b44e-3910afdbb964 61 fields · synced May 16, 2026