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Disposable Anesthesia Masks
EUDAMEDClass IIa (EU MDR)
Ref MZM-02-02Model MZMRef MZM-01-07Ref MZM-02-06Ref MZM-02-07Ref MZM-02-03Ref MZM-01-02Ref MZM-01-04Ref MZM-02-05Ref MZM-02-01Ref MZM-01-06Ref MZM-01-03
Identity
- Trade Name
- Disposable Anesthesia Masks EUDAMED
- Device Name
- Disposable Anesthesia Masks EUDAMED
- Model / Reference
- MZM EUDAMEDMZM-02-02 EUDAMEDMZM-01-07 EUDAMEDMZM-02-06 EUDAMEDMZM-02-07 EUDAMEDMZM-02-03 EUDAMEDMZM-01-02 EUDAMEDMZM-01-04 EUDAMEDMZM-02-05 EUDAMEDMZM-02-01 EUDAMEDMZM-01-06 EUDAMEDMZM-01-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531332622 EUDAMED06970531332625 EUDAMED26970531332728 EUDAMED16970531332653 EUDAMED06970531332748 EUDAMED06970531332632 EUDAMED06970531332670 EUDAMED26970531332698 EUDAMED16970531332646 EUDAMED06970531332656 EUDAMED26970531332674 EUDAMED06970531332618 EUDAMED06970531332717 EUDAMED16970531332721 EUDAMED16970531332684 EUDAMED06970531332687 EUDAMED26970531332681 EUDAMED06970531332731 EUDAMED06970531332724 EUDAMED16970531332714 EUDAMED06970531332663 EUDAMED16970531332677 EUDAMED
- Basic UDI-DI
- 697053133damVN EUDAMED
- Direct Marketing DI
- 16970531332622 EUDAMED06970531332625 EUDAMED26970531332728 EUDAMED16970531332653 EUDAMED06970531332748 EUDAMED06970531332632 EUDAMED06970531332670 EUDAMED26970531332698 EUDAMED16970531332646 EUDAMED06970531332656 EUDAMED26970531332674 EUDAMED06970531332618 EUDAMED06970531332717 EUDAMED16970531332721 EUDAMED16970531332684 EUDAMED06970531332687 EUDAMED26970531332681 EUDAMED06970531332731 EUDAMED06970531332724 EUDAMED16970531332714 EUDAMED06970531332663 EUDAMED16970531332677 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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: Anaesthesia face mask, single-use
Disposable Anesthesia Masks by Shaoxing Undis Medical Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 697053133damVN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (22)
- EUDAMED d7924e6d-a468-4308-b9b1-dbc75951a369 61 fields · synced Sep 17, 2026
- EUDAMED ce829856-995d-41c4-a305-c7e42c071a4a 61 fields · synced May 16, 2026
- EUDAMED d7e93047-84d9-4187-b87b-4c081dcfab5a 61 fields · synced May 16, 2026
- EUDAMED fbb46a78-2e54-4a11-8772-da8aca0f0fcd 61 fields · synced May 16, 2026
- EUDAMED c11f3ec5-0f6a-440b-9770-b61decd7878c 61 fields · synced May 16, 2026
- EUDAMED 143a90e0-a7a1-4254-9e1f-a33aa656a619 61 fields · synced May 16, 2026
- EUDAMED b858faa4-3b45-4d5d-b24f-ec359b044553 61 fields · synced May 16, 2026
- EUDAMED edf49a22-82c9-496b-85c1-a79b7241ab71 61 fields · synced May 17, 2026
- EUDAMED 8f2ac36c-033c-4436-ae97-8b58527143f0 61 fields · synced May 17, 2026
- EUDAMED 614ec873-7d9d-4eb9-a1a3-e99318d1d30d 61 fields · synced May 17, 2026
- EUDAMED 1d353fc1-bee2-400f-840c-b5e1b1ee0c9f 61 fields · synced May 17, 2026
- EUDAMED 6d2c0b85-199d-422d-b1f3-8d10cd1589ea 61 fields · synced May 17, 2026
- EUDAMED ee9f9c6c-6a98-4db9-9a60-3e5ff4c35528 61 fields · synced May 17, 2026
- EUDAMED 33b3e748-41b6-4e4f-a986-998c1ae68085 61 fields · synced May 17, 2026
- EUDAMED 09e5ff8d-d8bc-494a-b745-05dc85317165 61 fields · synced May 18, 2026
- EUDAMED 1f9cb0fb-412b-44d2-bf24-7a0d49edb251 61 fields · synced May 19, 2026
- EUDAMED aa36a7dd-9cc9-43a2-a363-1a8f83d0ca16 61 fields · synced May 19, 2026
- EUDAMED 41e67829-1c69-41e6-a8d9-01391a63c70a 61 fields · synced May 19, 2026
- EUDAMED 83097bb8-4b46-438c-b85e-61b5b19d7cf3 61 fields · synced May 19, 2026
- EUDAMED 3881fa5e-b609-40e7-b911-896b11cae586 61 fields · synced May 19, 2026
- EUDAMED 0da92145-cad2-4e90-ad25-ea137469dea6 61 fields · synced May 19, 2026
- EUDAMED bb2c3bb8-9d47-4673-bfcd-d8bc921c9410 61 fields · synced May 19, 2026