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Thermoforming Sheet

EUDAMED

Class I (EU MDR)

Ref T-ECDA-343-F125-076-ERef T-ECDA-BA1-343-F125-076-ERef M-EA-100-F125-050-NRef T-ECDA-343-R137-076-ERef T-ECDA-343-R137-076-NRef T-DAEA-151-F125-076-ERef T-ECDA-343-F133-076-KRef M-EC-100-F120-076-ERef M-CS-100-F125-070-NRef M-EC-100-F120-100-ERef M-EA-100-F125-100-KRef T-ECDA-343-R102-076-NRef T-ECDA-343-F120-076-CRef M-EC-100-F125-076-ERef M-EA-100-R137-076-PRef M-EA-100-F125-076-KRef T-DAEA-151-F125-076-NRef M-EC-100-F125-076-NRef T-ECDA-343-F133-076-ERef T-ECDA-343-R137-076-KRef T-ECDA-343-R102-076-P

by Shanghai Maxflex Medical Technology Co., Ltd.

Identity

Device Name
Thermoforming Sheet EUDAMED
Model / Reference
T-ECDA-343-F125-076-E EUDAMED
T-ECDA-BA1-343-F125-076-E EUDAMED
M-EA-100-F125-050-N EUDAMED
T-ECDA-343-R137-076-E EUDAMED
T-ECDA-343-R137-076-N EUDAMED
T-DAEA-151-F125-076-E EUDAMED
T-ECDA-343-F133-076-K EUDAMED
M-EC-100-F120-076-E EUDAMED
M-CS-100-F125-070-N EUDAMED
M-EC-100-F120-100-E EUDAMED
M-EA-100-F125-100-K EUDAMED
T-ECDA-343-R102-076-N EUDAMED
T-ECDA-343-F120-076-C EUDAMED
M-EC-100-F125-076-E EUDAMED
M-EA-100-R137-076-P EUDAMED
M-EA-100-F125-076-K EUDAMED
T-DAEA-151-F125-076-N EUDAMED
M-EC-100-F125-076-N EUDAMED
T-ECDA-343-F133-076-E EUDAMED
T-ECDA-343-R137-076-K EUDAMED
T-ECDA-343-R102-076-P EUDAMED

Identifiers

Primary DI / UDI-DI
06975063091965 EUDAMED
06975063094133 EUDAMED
06975063092085 EUDAMED
06975063092689 EUDAMED
06975063091231 EUDAMED
06975063092436 EUDAMED
06975063092023 EUDAMED
06975063092108 EUDAMED
06975063094454 EUDAMED
06975063092092 EUDAMED
06975063092368 EUDAMED
06975063091866 EUDAMED
06975063091309 EUDAMED
06975063092443 EUDAMED
06975063092405 EUDAMED
06975063092382 EUDAMED
06975063092429 EUDAMED
06975063091057 EUDAMED
06975063091972 EUDAMED
06975063092009 EUDAMED
06975063092016 EUDAMED
Basic UDI-DI
697506309TSMUQ EUDAMED
EMDN Code
Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France 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

Thermoforming Sheet by Shanghai Maxflex Medical Technology 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

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Manufacturer

Manufacturer
Shanghai Maxflex Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000032435
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (21)

  • EUDAMED 5e3eb423-7679-4a68-a417-c48dd2bdedf2 61 fields · synced Aug 4, 2026
  • EUDAMED 41a3ea81-2d61-40b2-b6ed-b0c90b14fd5c 61 fields · synced May 16, 2026
  • EUDAMED 792b0382-5ced-4d31-8e90-6f8ae62f2904 61 fields · synced May 16, 2026
  • EUDAMED ab9d1c68-5ddc-4b7e-abfd-9ed1a0bc1d57 61 fields · synced May 16, 2026
  • EUDAMED bf9e19f8-9973-4b07-95a5-1707b2a2319f 61 fields · synced May 17, 2026
  • EUDAMED 72187793-5535-4696-aadd-3c216fac3c8c 61 fields · synced May 17, 2026
  • EUDAMED 58746114-8a2f-4ab2-82ef-77ead9f95b5f 61 fields · synced May 17, 2026
  • EUDAMED 0aedad86-477e-415c-bcd8-a6d69893e682 61 fields · synced May 17, 2026
  • EUDAMED 05d26e1a-7ce3-437b-8e8b-e16775d756e3 61 fields · synced May 17, 2026
  • EUDAMED b20c1c53-09bf-4572-a44f-3cc1656f5f97 61 fields · synced May 17, 2026
  • EUDAMED e3dc10a5-5073-4dd6-b185-4d1cb68b6d7a 61 fields · synced May 18, 2026
  • EUDAMED d868a624-582b-47f8-98b3-c6288d5f8387 61 fields · synced May 18, 2026
  • EUDAMED 27819064-7f03-4f2f-ad86-fb6bdec6222a 61 fields · synced May 18, 2026
  • EUDAMED ba573499-a4b9-4a4d-8a25-96e33fbd6fdb 61 fields · synced May 18, 2026
  • EUDAMED 038a0752-11c9-4ad8-8374-4a2e325c28af 61 fields · synced May 18, 2026
  • EUDAMED be9c979f-f43f-42dc-a52c-7f0f0b4474d1 61 fields · synced May 18, 2026
  • EUDAMED 51074ea7-8d3f-46de-9c15-cafa8016f975 61 fields · synced May 19, 2026
  • EUDAMED b2d3e525-442c-47bc-ac8b-b861a67c3d23 61 fields · synced May 19, 2026
  • EUDAMED 9ca00999-8f85-44b0-88dd-1491b1bf4e90 61 fields · synced May 19, 2026
  • EUDAMED 2f321423-a7ed-433a-b24f-e56b89fc4bcb 61 fields · synced May 19, 2026
  • EUDAMED b0b138b6-ccf1-4bb9-9a0c-1e1a53ff2298 61 fields · synced May 19, 2026