Drainage System
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Drainage System EUDAMEDWellead Evacuator FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Drainage System EUDAMED200cc FDA UDI
- Model / Reference
- Silicone Reservoir EUDAMEDN01E012010 EUDAMEDFDA UDI
- Description
- 200cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881168802 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FN01E01HV EUDAMED
- FDA Product Code
- FFD FDA UDI
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4370 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Suction/irrigation tubing, single-use
Drainage System by Well Lead Medical Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
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- Disposable Suction Connecting Tube — Hangzhou Hawk Medical Technology Co., Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69449327FN01E01HV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006728
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 62953692-707f-4e04-b871-068a06887683 61 fields · synced Oct 6, 2026
- FDA UDI ecc97164-55cc-4426-ab7b-1efe8f106bcd 33 fields · synced May 30, 2026