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Sterile Gauze Balls
EUDAMEDClass I (EU MDR)
Ref C103221Ref C103126Ref C103153Ref C103128Ref C103122Ref C103035Ref C103220Ref C103028Ref C103025Ref C103027Ref C103037Ref C103127Ref C103021Ref C103162Ref C103041Ref C103039Ref C103125Ref C103032Ref C103143
Identity
- Trade Name
- Sterile Gauze Balls EUDAMED
- Device Name
- Sterile Gauze Balls EUDAMED
- Model / Reference
- C103221 EUDAMEDC103126 EUDAMEDC103153 EUDAMEDC103128 EUDAMEDC103122 EUDAMEDC103035 EUDAMEDC103220 EUDAMEDC103028 EUDAMEDC103025 EUDAMEDC103027 EUDAMEDC103037 EUDAMEDC103127 EUDAMEDC103021 EUDAMEDC103162 EUDAMEDC103041 EUDAMEDC103039 EUDAMEDC103125 EUDAMEDC103032 EUDAMEDC103143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936662651165 EUDAMED06936662600651 EUDAMED06936662603997 EUDAMED06936662600675 EUDAMED06936662600613 EUDAMED06971872208426 EUDAMED06936662651158 EUDAMED06971872208419 EUDAMED06971872208334 EUDAMED06971872208303 EUDAMED06971872208372 EUDAMED06936662600668 EUDAMED06971872208310 EUDAMED06936662604802 EUDAMED06971872208600 EUDAMED06971872208280 EUDAMED06936662600644 EUDAMED06971872208396 EUDAMED06936662603720 EUDAMED
- Basic UDI-DI
- 693666261031001RJ EUDAMED6971872201031001LC EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Intranasal splint, non-biodegradable
Sterile Gauze Balls by Kingstar Medical (Xianning) Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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- Custom Nasal Splint — Boston Medical Products, Inc. · Class I
- Doyle II™ — MEDTRONIC XOMED, INC. · Class I
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 | 693666261031001RJ | Class I | Active |
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Manufacturer
- Manufacturer
- Kingstar Medical (Xianning) Co., LTD
- EUDAMED SRN
- CN-MF-000006015
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (19)
- EUDAMED 11e2f9a1-7394-4155-9ec1-4772efa19439 61 fields · synced Sep 17, 2026
- EUDAMED 1b1db511-1501-443d-820c-cb37182157df 61 fields · synced May 11, 2026
- EUDAMED 398ff98e-c816-4eee-8a96-ed5905a8ae84 61 fields · synced May 16, 2026
- EUDAMED 505dec93-436c-470a-9a99-41c2662d7170 61 fields · synced May 17, 2026
- EUDAMED e5b12215-7cb4-4654-bcf4-6f6a5be941bc 61 fields · synced May 17, 2026
- EUDAMED a6c21f9e-b3f9-45f7-b66c-395bbe86d77a 61 fields · synced May 17, 2026
- EUDAMED 35046e43-e7ab-4f94-998d-ee993136e4ef 61 fields · synced May 17, 2026
- EUDAMED 39496792-6ae8-4190-8e0d-211b1a4ecb79 61 fields · synced May 17, 2026
- EUDAMED 65091880-33e0-40d6-9a65-05c49161e4e8 61 fields · synced May 17, 2026
- EUDAMED 5b10ed26-9a0c-49a7-a4db-d958713a29f7 61 fields · synced May 17, 2026
- EUDAMED 7b190f46-6d42-468f-a913-179b10a3ab5e 61 fields · synced May 18, 2026
- EUDAMED 4fedfcbc-220a-4a5a-b166-c4a51126c8dd 61 fields · synced May 18, 2026
- EUDAMED 2008242b-002f-48bf-ba32-fff841547f41 61 fields · synced May 18, 2026
- EUDAMED c3ab8eb0-e226-4172-bc70-948d55431e1b 61 fields · synced May 18, 2026
- EUDAMED 067887e8-3d4e-4761-8e35-063f78bf46ad 61 fields · synced May 18, 2026
- EUDAMED 3949bfb0-2cdf-49c9-b987-d1ff2bc10114 61 fields · synced May 18, 2026
- EUDAMED eb2883bc-2d11-4adb-96a9-191c51e84052 61 fields · synced May 18, 2026
- EUDAMED 1f24161b-7c24-4bed-9b7b-cb97fd8efea0 61 fields · synced May 18, 2026
- EUDAMED fd690b69-b883-4028-ad9b-c2f0a2f584c7 61 fields · synced May 19, 2026