← Back to catalogue
Pharmaphile Hydrolast Elastic Bandage
EUDAMEDClass I (EU MDR)
Ref 10442100Model FB6, FB8Ref 10445200
Identity
- Trade Name
- Pharmaphile Hydrolast Elastic Bandage EUDAMED
- Device Name
- First Aid Dressing Bandage EUDAMED
- Model / Reference
- FB6, FB8 EUDAMED10442100 EUDAMED10445200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454767343 EUDAMED06951454734338 EUDAMED
- Basic UDI-DI
- 69514547300UW EUDAMED
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Pharmaphile Hydrolast Elastic Bandage by Gauke Healthcare Co., 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 | 69514547300UW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 6a1c5a04-d0b3-4239-9a13-64c466904296 61 fields · synced Oct 6, 2026
- EUDAMED ee32777d-15c8-4c30-aa60-0ee9b6eddcd8 61 fields · synced May 19, 2026