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evercare® Surgical sponges, x-ray detectable, nonwoven, diam. 27 mm, 5-pack
EUDAMEDClass IIa (EU MDR)
Ref 3113-01
Identity
- Trade Name
- evercare® Surgical sponges, x-ray detectable, nonwoven, diam. 27 mm, 5-pack EUDAMED
- Device Name
- Surgical Sponges XRD Nonwoven, sterile EUDAMED
- Model / Reference
- 3113-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129120950 EUDAMED
- Basic UDI-DI
- 6438129B0038HK EUDAMED
- EMDN Code
- M0202030201 NON-WOVEN GAUZE PADS, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa 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® Surgical sponges, x-ray detectable, nonwoven, diam. 27 mm, 5-pack by OneMed Group Oy — Class IIa — 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 | 6438129B0038HK | Class IIa | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 2a5069c5-4d1f-4208-9a44-414328bb2627 61 fields · synced Jun 18, 2026