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welsuc
EUDAMEDClass IIb (EU MDR)
Ref 43010112Model PU-IIIRef 43010120Ref 43010114Ref 43010122Ref 43010106Ref 43010121Ref 43010116Ref 43010110Ref 43010101Ref 43010113Ref 43010124Ref 43010103Ref 43010115Ref 43010125Ref 43010104Ref 43020103Model RH-450Ref 43010102Ref 43020101Ref 43010109Ref 43020100
Identity
- Trade Name
- welsuc EUDAMED
- Device Name
- Negative Pressure Wound Therapy Dressing Kit EUDAMEDSterile Negative Pressure Wound Therapy Dressing Kit EUDAMEDNegative pressure wound therapy device EUDAMED
- Model / Reference
- PU-III EUDAMED43010112 EUDAMED43010120 EUDAMED43010114 EUDAMED43010122 EUDAMED43010106 EUDAMED43010121 EUDAMED43010116 EUDAMED43010110 EUDAMED43010101 EUDAMED43010113 EUDAMED43010124 EUDAMED43010103 EUDAMED43010115 EUDAMED43010125 EUDAMED43010104 EUDAMEDRH-450 EUDAMED43020103 EUDAMED43010102 EUDAMED43020101 EUDAMED43010109 EUDAMED43020100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938294453117 EUDAMED06938294453193 EUDAMED06938294453131 EUDAMED06938294453216 EUDAMED06938294453056 EUDAMED06938294453209 EUDAMED06938294453155 EUDAMED06938294453094 EUDAMED06938294453001 EUDAMED06938294453124 EUDAMED06938294453230 EUDAMED06938294453025 EUDAMED06938294453148 EUDAMED06938294453384 EUDAMED06938294453032 EUDAMED06938294470787 EUDAMED06938294453018 EUDAMED06938294453247 EUDAMED06938294470763 EUDAMED06938294453087 EUDAMED06938294470749 EUDAMED
- Basic UDI-DI
- 69382944PU000UE EUDAMED69382944PU001UG EUDAMED69382944FYJ450V4 EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
welsuc by Guangzhou Rainhome Pharm & Tech Co., Ltd — Class IIb — 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 | 69382944PU000UE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangzhou Rainhome Pharm & Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000027876
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (21)
- EUDAMED 9048814a-a6d1-44f7-a6db-14a1b9c8c1ee 61 fields · synced Sep 17, 2026
- EUDAMED 064d671f-a1e2-4852-902d-d6a8e55a35f9 61 fields · synced May 11, 2026
- EUDAMED c9f274cd-47bb-4cd1-9a52-863c80744c8a 61 fields · synced May 16, 2026
- EUDAMED b1e24e36-551f-450a-b3d0-b7af4c0c2dc1 61 fields · synced May 16, 2026
- EUDAMED 53cdfbed-e1e0-48a4-af6f-f72b09599458 61 fields · synced May 16, 2026
- EUDAMED a4af63ca-79fa-4524-9f21-2cd77b5d0d03 61 fields · synced May 17, 2026
- EUDAMED 49af52e8-dc4d-44b0-a0c3-a66cf76cf6b9 61 fields · synced May 17, 2026
- EUDAMED 8288bdef-ea8d-4abd-b608-7e4e966dbe11 61 fields · synced May 17, 2026
- EUDAMED 80bbdd72-b929-4a83-bcca-8ca250117c20 61 fields · synced May 17, 2026
- EUDAMED b72cc0aa-eed6-4fb4-b4d6-e481abf90986 61 fields · synced May 17, 2026
- EUDAMED 21ba7824-79d6-4bfc-a3e5-4281f6793607 61 fields · synced May 17, 2026
- EUDAMED 9cfdd7ab-dc13-456a-a6ca-0aefd607e0ac 61 fields · synced May 17, 2026
- EUDAMED 89708c7a-8983-44bb-9c46-05e0e9db1dbd 61 fields · synced May 17, 2026
- EUDAMED b0126073-3a28-449b-bc4f-efbed7180d49 61 fields · synced May 17, 2026
- EUDAMED 9ab0ed9f-00be-4feb-a0c1-8ec98b2caf0c 61 fields · synced May 17, 2026
- EUDAMED f8e3456c-217b-430d-86fd-742acfadd451 61 fields · synced May 18, 2026
- EUDAMED 11bdf03a-3822-46a0-a7f3-f9ece0afcf4b 61 fields · synced May 18, 2026
- EUDAMED aaa01eaa-a4be-4e29-afc0-901153e79212 61 fields · synced May 18, 2026
- EUDAMED 5ca6d2b9-a26f-475c-8998-0dc517b8f724 61 fields · synced May 18, 2026
- EUDAMED 62e1abef-798f-4848-9142-4435fc4f0cc7 61 fields · synced May 19, 2026
- EUDAMED f2fa79f9-ca01-4f1d-9aa9-fa2fc1e2ccd8 61 fields · synced May 19, 2026