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extriCARE® Negative Pressure Wound Therapy Pump
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MI388Model extriCARE® 1000
Identity
- Trade Name
- extriCARE® Negative Pressure Wound Therapy Pump EUDAMEDExtriCARE FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, reusable FDA UDI
- Device Name
- extriCARE® Negative Pressure Wound Therapy Pump EUDAMEDExtricare 1000 Negative Pressure Wound Therapy Pump FDA UDI
- Model / Reference
- extriCARE® 1000 EUDAMEDMI388 EUDAMEDMI388-0001 FDA UDI
- Description
- Extricare 1000 Negative Pressure Wound Therapy Pump FDA UDI
Identifiers
- Catalog Number
- EC1000 FDA UDI
- Primary DI / UDI-DI
- 04897089070323 EUDAMEDFDA UDI
- Basic UDI-DI
- 489708907MI388KZ EUDAMED
- Direct Marketing DI
- 04897089070323 EUDAMED
- 510(k) Number
- K213906 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
- GMDN Term
- Negative-pressure wound therapy system, electric, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
extriCARE® Negative Pressure Wound Therapy Pump by Alleva Medical Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489708907MI388KZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Alleva Medical Limited
- EUDAMED SRN
- CN-MF-000018963
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 6f90fba6-b9e2-4907-8c35-128c6b2a7696 61 fields · synced Jul 13, 2026
- FDA UDI a6e87585-8c39-40f0-9da6-0dfad9eee840 35 fields · synced May 30, 2026