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UNIVERSAL MASK HARD TOUCH adultos
EUDAMEDClass I (EU MDR)
Ref 410011054Model DL-F-I/C/L, DL-FB-I/C/L, DL-FP-I/C/L, DL-FF-I/C/L, DL-FFP-I/C/L, DL-R-I/C/L, DL-RC-I/C/L/II/D/H/CC, DL-RP-I/C/L, DL-U-S/M/L, DL-UP-S/M/L, DL-DP-S/M/L, DL-OR-S/M/L, DL-DR-S/M/L, DL-OP-S/M/L
Identity
- Trade Name
- UNIVERSAL MASK HARD TOUCH adultos EUDAMED
- Device Name
- Face Masks EUDAMED
- Model / Reference
- DL-F-I/C/L, DL-FB-I/C/L, DL-FP-I/C/L, DL-FF-I/C/L, DL-FFP-I/C/L, DL-R-I/C/L, DL-RC-I/C/L/II/D/H/CC, DL-RP-I/C/L, DL-U-S/M/L, DL-UP-S/M/L, DL-DP-S/M/L, DL-OR-S/M/L, DL-DR-S/M/L, DL-OP-S/M/L EUDAMED410011054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701962171 EUDAMED
- Basic UDI-DI
- 697070196410021018KM EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
UNIVERSAL MASK HARD TOUCH adultos by Taian Dalu Medical Instrument 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 | 697070196410021018KM | Class I | Active |
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Manufacturer
- Manufacturer
- Taian Dalu Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003009
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6ebe4043-4204-49e8-a681-d38489c5aeac 61 fields · synced Jun 19, 2026