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Relifoam Silicone Hydrophilic Foam Dressing
EUDAMEDClass I (EU MDR)
Ref 4138-011-(10cm x 10cm)Model HYFDRef 4138-014-(10cm x 20cm)Ref 4138-013-(17.5cm x 17.5cm)Ref 4138-018-(10cm x 30cm)Ref 4138-005-(12.5cm x 12.5cm)Ref 4138-016 -(10cm x 25cm)
Identity
- Trade Name
- Relifoam Silicone Hydrophilic Foam Dressing EUDAMED
- Device Name
- Hydrophilic Foam Dressings EUDAMED
- Model / Reference
- HYFD EUDAMED4138-011-(10cm x 10cm) EUDAMED4138-014-(10cm x 20cm) EUDAMED4138-013-(17.5cm x 17.5cm) EUDAMED4138-018-(10cm x 30cm) EUDAMED4138-005-(12.5cm x 12.5cm) EUDAMED4138-016 -(10cm x 25cm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044234099 EUDAMED08904044234129 EUDAMED08904044234112 EUDAMED08904044234143 EUDAMED08904044213988 EUDAMED08904044234136 EUDAMED
- Basic UDI-DI
- 89040442HFWDQP EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I 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: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Relifoam Silicone Hydrophilic Foam Dressing by Dynamic Techno Medicals Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 89040442HFWDQP | Class I | Active |
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Manufacturer
- Manufacturer
- Dynamic Techno Medicals Pvt Ltd
- EUDAMED SRN
- IN-MF-000017845
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (6)
- EUDAMED 434daf01-0681-4777-84f3-984d2ce38e76 61 fields · synced Oct 6, 2026
- EUDAMED 49713389-dc45-4d42-9e03-66d167cb7396 61 fields · synced May 17, 2026
- EUDAMED b012c854-f61a-4c62-abf5-c81c9fad030e 61 fields · synced May 17, 2026
- EUDAMED f91e1f6f-e8ca-49d1-995b-c915611502f2 61 fields · synced May 18, 2026
- EUDAMED f40addb2-1bba-4445-8bc9-1d5a82bbb802 61 fields · synced May 18, 2026
- EUDAMED cddc7469-a032-4bfa-a8a1-ca71e815ccab 61 fields · synced May 18, 2026