← Back to catalogue
PRIMA PPSB Gauze Swabs, 10cm x 10cm, sterile, 2pcs/bag (1684-10X10)
EUDAMEDClass I (EU MDR)
Ref 1684-10x10
Identity
- Trade Name
- PRIMA PPSB Gauze Swabs, 10cm x 10cm, sterile, 2pcs/bag (1684-10X10) EUDAMED
- Device Name
- Absorbent non woven Compress EUDAMED
- Model / Reference
- 1684-10x10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454706977 EUDAMED
- Basic UDI-DI
- 69514547317VF EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
PRIMA PPSB Gauze Swabs, 10cm x 10cm, sterile, 2pcs/bag (1684-10X10) by Gauke Healthcare Co., Ltd — Class I — 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 | 69514547317VF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 655ac24a-83cc-41bc-87be-a1cd7bcb5914 61 fields · synced Oct 7, 2026