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evercare® Surgical swabs, x-ray detectable, gauze, 10x10 cm, 12-ply, sewn, 5-pa…
EUDAMEDClass IIa (EU MDR)
Ref 3220-01
Identity
- Trade Name
- evercare® Surgical swabs, x-ray detectable, gauze, 10x10 cm, 12-ply, sewn, 5-pack EUDAMED
- Device Name
- Surgical Swabs XRD Gauze, sterile EUDAMED
- Model / Reference
- 3220-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129119503 EUDAMED
- Basic UDI-DI
- 6438129B0035HD EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, 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 swabs, x-ray detectable, gauze, 10x10 cm, 12-ply, sewn, 5-pa… 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 | 6438129B0035HD | Class IIa | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED bda18b4e-010e-4b1e-acb8-6fa66259a9e0 61 fields · synced Jul 9, 2026