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JF1004 - (JF0954) JFA Sterile Gauze Swabs 10x10cm pouch
EUDAMEDClass I (EU MDR)
Ref JF1004 - (JF0954) Model JF0952
Identity
- Trade Name
- JF1004 - (JF0954) JFA Sterile Gauze Swabs 10x10cm pouch EUDAMED
- Device Name
- STERILE GAUZE SWAB EUDAMED
- Model / Reference
- JF0952 EUDAMEDJF1004 - (JF0954) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942694602273 EUDAMED
- Basic UDI-DI
- 697386485JFASWAB8M EUDAMED
- Direct Marketing DI
- 06942694602273 EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
JF1004 - (JF0954) JFA Sterile Gauze Swabs 10x10cm pouch by Suzhou Sunmed Co., Ltd. — 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 | 697386485JFASWAB8M | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 8a69e882-ac38-49eb-bfeb-393d0d874a1b 61 fields · synced Jun 18, 2026
- EUDAMED 9eaa9d1f-c0f9-44ff-a14a-4011e7d5e949 61 fields · synced Jun 18, 2026