Disposable Bite Trays

EUDAMED

Class I (EU MDR)

Ref ITB-102Ref ITB-106Ref ITRL-004Ref ITRL-006Ref ITB-101Ref ITB-105Ref ITRL-003Ref FT-002Ref 8844Ref FT-001WRef 8842Ref FT-003Ref 8843Ref ITB-103Ref PFT-095/3504Model 095/3504Ref PFT-095/3500Model 095/3500Ref PFT-011/3034Model 011/3034Ref PFT-011/3032Model 011/3032Ref 011/3036Ref PFT-095/3502Model 095/3502Ref PFT-095/3501Model 095/3501Ref PFT-011/2000Model 011/2000Ref PFT-011/2003Model 011/2003Ref 011/3037Ref PFT-011/2002Model 011/2002Ref 011/3030Ref PFT-011/3037Ref PFT-011/2001Model 011/2001Ref 011/3031Ref 011/3033Ref 011/3035Ref PFT-011/3038Model 011/3038Ref PFT-011/3030Ref PFT-011/2004Model 011/2004Ref PFT-011/3033

by Wellmed Dental Medical Supply Co., Ltd

Identity

Device Name: Disposable Bite Trays EUDAMED
Model / Reference: ITB-102 EUDAMED
ITB-106 EUDAMED
ITRL-004 EUDAMED
ITRL-006 EUDAMED
ITB-101 EUDAMED
ITB-105 EUDAMED
ITRL-003 EUDAMED
FT-002 EUDAMED
8844 EUDAMED
FT-001W EUDAMED
8842 EUDAMED
FT-003 EUDAMED
8843 EUDAMED
ITB-103 EUDAMED
095/3504 EUDAMED
PFT-095/3504 EUDAMED
095/3500 EUDAMED
PFT-095/3500 EUDAMED
011/3034 EUDAMED
PFT-011/3034 EUDAMED
011/3032 EUDAMED
PFT-011/3032 EUDAMED
011/3036 EUDAMED
095/3502 EUDAMED
PFT-095/3502 EUDAMED
095/3501 EUDAMED
PFT-095/3501 EUDAMED
011/2000 EUDAMED
PFT-011/2000 EUDAMED
011/2003 EUDAMED
PFT-011/2003 EUDAMED
011/3037 EUDAMED
011/2002 EUDAMED
PFT-011/2002 EUDAMED
011/3030 EUDAMED
PFT-011/3037 EUDAMED
011/2001 EUDAMED
PFT-011/2001 EUDAMED
011/3031 EUDAMED
011/3033 EUDAMED
011/3035 EUDAMED
011/3038 EUDAMED
PFT-011/3038 EUDAMED
PFT-011/3030 EUDAMED
011/2004 EUDAMED
PFT-011/2004 EUDAMED
PFT-011/3033 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974608655136 EUDAMED
06974608655198 EUDAMED
06974608654719 EUDAMED
06974608657673 EUDAMED
16974608657700 EUDAMED
06974608654702 EUDAMED
06974608654740 EUDAMED
06974608657666 EUDAMED
06974608650919 EUDAMED
06974608654467 EUDAMED
06974608653729 EUDAMED
06974608654443 EUDAMED
06974608650926 EUDAMED
06974608654450 EUDAMED
16974608657670 EUDAMED
06974608654726 EUDAMED
05060660619306 EUDAMED
15060660619266 EUDAMED
15060660617460 EUDAMED
05060660617463 EUDAMED
15060660617446 EUDAMED
05060660617487 EUDAMED
05060660619283 EUDAMED
05060660619276 EUDAMED
05060660617364 EUDAMED
15060660617392 EUDAMED
05060660617449 EUDAMED
05060660617494 EUDAMED
05060660617388 EUDAMED
15060660617422 EUDAMED
15060660617491 EUDAMED
05060660619269 EUDAMED
15060660617378 EUDAMED
15060660617439 EUDAMED
15060660619273 EUDAMED
15060660617453 EUDAMED
15060660617477 EUDAMED
15060660617385 EUDAMED
05060660617500 EUDAMED
05060660617425 EUDAMED
15060660619303 EUDAMED
15060660617408 EUDAMED
05060660617456 EUDAMED
Basic UDI-DI: 697460865ITB-102R3 EUDAMED
697460865ITB-106RB EUDAMED
697460865ITRL-004EU EUDAMED
697460865ITRL-006EY EUDAMED
697460865ITB-101QZ EUDAMED
697460865ITB-105R9 EUDAMED
697460865ITRL-003ES EUDAMED
697460865FT-002G6 EUDAMED
6974608658844FX EUDAMED
697460865FT-001WKF EUDAMED
6974608658842FT EUDAMED
697460865FT-003G8 EUDAMED
6974608658843FV EUDAMED
697460865ITB-103R5 EUDAMED
697460865095/3504XP EUDAMED
697460865095/3500XF EUDAMED
697460865011/3034RB EUDAMED
697460865011/3032R7 EUDAMED
697460865011/3036RF EUDAMED
697460865095/3502XK EUDAMED
697460865095/3501XH EUDAMED
697460865011/2000QK EUDAMED
697460865011/2003QR EUDAMED
697460865011/3037RH EUDAMED
697460865011/2002QP EUDAMED
697460865011/3030R3 EUDAMED
697460865011/2001QM EUDAMED
697460865011/3031R5 EUDAMED
697460865011/3033R9 EUDAMED
697460865011/3035RD EUDAMED
697460865011/3038RK EUDAMED
697460865011/2004QT EUDAMED
EMDN Code: Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Dental impression tray, single-use

Disposable Bite Trays by Wellmed Dental Medical Supply Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Dental impression tray, single-use.

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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	697460865ITB-102R3	Class I	Active

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Manufacturer

Manufacturer: Wellmed Dental Medical Supply Co., Ltd
EUDAMED SRN: CN-MF-000003243
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (43)

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EUDAMED 428d226a-a2b4-41cb-86a0-6cec5318d679 61 fields · synced Aug 4, 2026
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