← Back to catalogue
Peha-soft Disposable Nitrile Gloves, 3.5g，Powder-free, Blue, L size
EUDAMEDClass I (EU MDR)
Ref 942028Model EM0102
Identity
- Trade Name
- Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, L size EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMED942028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265559881 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265559881 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Peha-soft Disposable Nitrile Gloves, 3.5g，Powder-free, Blue, L size by Blue Sail Medical Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 69332655EM01021562864B | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Sail Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001139
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d7888eab-f3e0-4a09-aee8-72053c084423 61 fields · synced Jun 19, 2026