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Derma Shield
EUDAMEDClass I (EU MDR)
Ref CANFULDSA0500Ref BOTFUL100UKRef P-LOTPOUCHRef CANFULDSA0150
Identity
- Trade Name
- Derma Shield EUDAMED
- Device Name
- Derma Shield EUDAMED
- Model / Reference
- CANFULDSA0500 EUDAMEDBOTFUL100UK EUDAMEDP-LOTPOUCH EUDAMEDCANFULDSA0150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060655504150 EUDAMED05060655504167 EUDAMED05060655504891 EUDAMED05060655504143 EUDAMED
- Basic UDI-DI
- 506065550DermaShieldM5 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Derma Shield by Unigloves (UK) Limited — 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 | 506065550DermaShieldM5 | Class I | Active |
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Manufacturer
- Manufacturer
- Unigloves (UK) Limited
- EUDAMED SRN
- GB-MF-000035139
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (4)
- EUDAMED 3fbff936-ddea-45cb-87d0-1cb2be8e2500 61 fields · synced Jul 30, 2026
- EUDAMED 0c9586c1-9f04-4c1c-8cf6-1d2c34ced867 61 fields · synced May 17, 2026
- EUDAMED be18cb28-e52a-42e1-9ae7-ab6a9180fe54 61 fields · synced May 19, 2026
- EUDAMED 13fbcee4-1c87-4e44-89c8-759cec6dac26 61 fields · synced May 19, 2026