← Back to catalogue
evercare® Abdominal swab, X-ray detectable, 45 x 70 cm, gauze, 5-pack
EUDAMEDClass IIa (EU MDR)
Ref 3312-01Ref 3311-01
Identity
- Trade Name
- evercare® Abdominal swab, X-ray detectable, 45 x 70 cm, gauze, 5-pack EUDAMEDevercare® Abdominal swab, X-ray detectable, 45 x 70 cm, gauze, 1-pack EUDAMED
- Device Name
- Surgical Swabs XRD Gauze, sterile EUDAMED
- Model / Reference
- 3312-01 EUDAMED3311-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129120226 EUDAMED06438129120219 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® Abdominal swab, X-ray detectable, 45 x 70 cm, gauze, 5-pack by OneMed Group Oy — 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 | 6438129B0035HD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED 07fca934-3e9a-472c-97c3-cd90e25b8c80 61 fields · synced Oct 7, 2026
- EUDAMED 830e2c53-dbee-488c-a5aa-b32d29d6b57b 61 fields · synced May 18, 2026