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Fluid Collection Pouch
EUDAMEDClass I (EU MDR)
Ref 17-1139NModel 17-1106EURef 17-1102NRef 17-1136NRef 17-1140NRef 14-6204EURef 14-6204FM
Identity
- Trade Name
- Fluid Collection Pouch EUDAMED
- Device Name
- Fluid collection pouch EUDAMED
- Model / Reference
- 17-1106EU EUDAMED17-1139N EUDAMED17-1102N EUDAMED17-1136N EUDAMED17-1140N EUDAMED14-6204EU EUDAMED14-6204FM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959221715122 EUDAMED06959221714019 EUDAMED06959221716570 EUDAMED06959221714804 EUDAMED06959221715351 EUDAMED06959221716266 EUDAMED
- Basic UDI-DI
- 69592217B001MU EUDAMED
- EMDN Code
- A06030499 INTRA-OPERATION FLUID COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Fluid Collection Pouch by Premier Guard Zhongshan 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 | 69592217B001MU | Class I | Active |
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Manufacturer
- Manufacturer
- Premier Guard Zhongshan Ltd.
- EUDAMED SRN
- CN-MF-000008071
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (6)
- EUDAMED 9f4b7ad7-2a1e-4a3d-97d9-e7586261fa67 61 fields · synced Jul 27, 2026
- EUDAMED adbb8970-1359-4982-9eb1-db9f149f04bb 61 fields · synced May 16, 2026
- EUDAMED 4cb7860e-5b70-4220-bd3c-6f61ffb5a931 61 fields · synced May 18, 2026
- EUDAMED c18b808c-d467-4845-95b7-463f294040eb 61 fields · synced May 18, 2026
- EUDAMED 96a337ef-4d1d-416f-9860-60f014a168b7 61 fields · synced May 19, 2026
- EUDAMED c0baeba7-fe6d-4cbc-ae67-7b4d75941195 61 fields · synced Jul 15, 2026